Case 1:22-cv-00441-HYJ-SJB ECF No. 1, PageID.1 Filed 05/16/22 Page 1 of 21
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF MICHIGAN
`SOUTHERN DIVISION
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`
`UNITED STATES OF AMERICA,
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`
`Plaintiff,
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`
`v.
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`ABBOTT LABORATORIES, a corporation
`doing business as ABBOTT NUTRITION, and
`KEENAN S. GALE, TJ HATHAWAY, and
`LORI J. RANDALL, individuals,
`
`
`Defendants.
`_____________________________________/
`
`
`Case No.
`
`Hon.
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`
`
`
`
`
`
`
`
`COMPLAINT FOR PERMANENT INJUNCTION
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`Plaintiff, the United States of America, by its undersigned counsel and on behalf of the
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`United States Food and Drug Administration (“FDA”), respectfully represents as follows:
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`1.
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`This action for a statutory injunction is brought under the Federal Food, Drug, and
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`Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), to permanently enjoin the defendants, Abbott
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`Laboratories, a corporation doing business as Abbott Nutrition, and Keenan S. Gale, TJ
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`Hathaway, and Lori J. Randall, individuals, (collectively, “Defendants”) from violating:
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`(a)
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`21 U.S.C. § 331(a), by introducing or causing to be introduced, or
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`delivering or causing to be delivered for introduction, into interstate commerce articles of food,
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`namely infant formulas, as defined in 21 U.S.C. § 321(z), that are adulterated within the meaning
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`of 21 U.S.C. § 350a(a)(3) in that they have been processed in a manner that does not comply
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`with current good manufacturing practice requirements for infant formula set forth at 21 U.S.C.
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`§ 350a(b)(2) and 21 C.F.R. Part 106;
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`(b)
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`21 U.S.C. § 331(a) by introducing or causing to be introduced, or
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`delivering or causing to be delivered for introduction, into interstate commerce articles of food
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`that are adulterated within the meaning of 21 U.S.C. § 342(a)(4) in that they have been prepared,
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`packed, or held under insanitary conditions whereby they may have become contaminated or
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`whereby they may have been rendered injurious to health;
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`(c)
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`21 U.S.C. § 331(k) by causing articles of food, namely infant formulas as
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`defined in 21 U.S.C. § 321(z), that are held for sale after shipment of one or more of their
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`components in interstate commerce to become adulterated within the meaning of 21 U.S.C.
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`§ 350a(a)(3); and
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`(d)
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`21 U.S.C. § 331(k) by causing articles of food that are held for sale after
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`shipment of one or more of their components in interstate commerce to become adulterated
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`within the meaning of 21 U.S.C. § 342(a)(4).
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`2.
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`Defendants manufacture infant formulas, including infant formulas in powdered
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`form (“powder infant formulas”), under conditions and practices that fail to protect the food
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`against the risk of contamination from bacteria including, but not limited to, Cronobacter
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`sakazakii (“C. sak.”) and Salmonella.
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`3.
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`C. sak. can live in dry foods, such as powder infant formula. In infants (children
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`younger than 12 months), C. sak. can be deadly. C. sak. can cause sepsis (a serious blood
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`infection) or meningitis (swelling of the linings surrounding the brain and spinal cord). Infants
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`two months or younger are most at risk of developing meningitis if they become ill from C. sak.
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`infection. Infants born prematurely are also more likely to become ill from C. sak. infection.
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`4.
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`FDA testing of environmental samples collected on or about February 1 or 2,
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`2022, detected C. sak. in a Sturgis, Michigan facility where Defendants manufactured powder
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`infant formula.
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`5.
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`Furthermore, Defendants identified Cronobacter spp. in their manufacturing
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`facility from their own environmental samples collected between February 6 and 20, 2022.
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`“Cronobacter spp.” refers to Cronobacter without a determination of the species, e.g., C. sak.
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`The presence of Cronobacter spp. in the manufacturing environment indicates that conditions
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`support bacterial growth and proliferation, including growth of pathogenic bacteria such as C.
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`sak. If speciation is not conducted, the findings of Cronobacter spp. must be treated as if the
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`bacteria are C. sak., for adequate protection of public health.
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`6.
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`On two previous occasions, Defendants detected Cronobacter spp. in their
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`finished powder infant formulas. (The contamination was caught before the infant formulas
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`were distributed to consumers.) Defendants processed/filled one batch of Cronobacter spp.-
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`positive product on or about August 18-19, 2019, and processed/filled the other batch of
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`Cronobacter spp.-positive product on or about June 12, 2020. The two finished product batches
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`that tested positive for Cronobacter spp. had been processed on different equipment; for
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`example, the products were dried on different spray dryers and filled on different filling lines.
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`(Spray dryers process infant formula or other food from a liquid form to powder form; this
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`process is known as “drying.” Filling lines are used for putting infant formula or other food into
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`containers and sealing the containers.) The presence of Cronobacter spp. on different processing
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`equipment at different times indicates the possibility of multiple avenues for spreading bacterial
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`contamination in the manufacturing environment.
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`7.
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`Ongoing inadequacies in manufacturing conditions and practices at Defendants’
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`facilities demonstrate that Defendants have been unwilling or unable to implement sustainable
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`corrective actions to ensure the safety and quality of food manufactured for infants, a consumer
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`group particularly vulnerable to foodborne pathogens. Defendants’ violations of the Act and the
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`likelihood that violations will recur in the absence of court action demonstrate that injunctive
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`relief is necessary.
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`Jurisdiction and Venue
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`8.
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`This Court has jurisdiction over the subject matter and all parties to this action
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`under 28 U.S.C. §§ 1331, 1337, and 1345, and 21 U.S.C. § 332(a).
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`9.
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`Venue in this district is proper under 28 U.S.C. § 1391(b) and (c).
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`Defendants and Their Operations
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`10.
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`Defendant Abbott Laboratories, doing business as Abbott Nutrition, is a
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`corporation formed under the laws of the State of Illinois. Abbott Nutrition manufactures infant
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`formulas at facilities located at 901 North Centerville Road, Sturgis, Michigan 49091 (“AN-
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`Sturgis”), within the jurisdiction of this Court. AN-Sturgis has over 400 employees.
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`11.
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`Defendant Keenan S. Gale holds the title of Director of Quality at AN-Sturgis and
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`oversees all quality assurance including, but not limited to, sanitation, compliance, and corrective
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`and preventive actions. Defendant Gale has the authority to detect, correct, and prevent
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`violations of the Act and its implementing regulations. Defendant Gale performs his duties at
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`AN-Sturgis, within the jurisdiction of this Court.
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`12.
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`Defendant TJ Hathaway is the Site Director at AN-Sturgis. Defendant Hathaway
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`has identified himself as the most responsible individual at the Sturgis Facility. Defendant
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`Hathaway is responsible for ensuring the safety and quality of products made at AN-Sturgis.
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`Defendant Hathaway performs his duties at AN-Sturgis, within the jurisdiction of this Court.
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`13.
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`Defendant Lori J. Randall is Abbott Nutrition’s Division Vice-President of
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`Quality Assurance. Defendant Randall has overall responsibility for quality operations for
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`global Abbott Nutrition, which includes, but is not limited to, oversight of manufacturing
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`locations and food safety, product quality, supplier quality, compliance, complaint management,
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`and corrective and preventive actions. Defendant Randall was responsible for approving the
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`decision made during FDA’s most-recent inspection at AN-Sturgis to initiate a recall of certain
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`infant formulas manufactured at AN-Sturgis. Defendant Randall performs her duties at Abbott
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`Laboratories’ corporate office located in Abbott Park, Illinois, where she conducts her oversight
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`duties for Abbott Laboratories’ manufacturing sites including, but not limited to, AN-Sturgis.
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`14.
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`During their regular course of business, Defendants manufacture, process, pack,
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`label, hold, and distribute articles of food, including infant formulas defined in 21 U.S.C.
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`§ 321(z), and food for older children. Defendants’ infant formulas and other food are marketed
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`under several brand names, including Similac (including Similac Alimentum) and EleCare.
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`15.
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`Defendants distribute their infant formulas throughout the United States,
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`including to Minnesota, Ohio, and Texas.
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`16.
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`Defendants manufacture their infant formulas using ingredients that were shipped
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`in interstate commerce, including ingredients from Illinois, Iowa, and Wisconsin.
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`Legal Framework
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`Infant Formula, Generally
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`17.
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`“Infant formula” means “a food which purports to be or is represented for special
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`dietary use solely as a food for infants by reason of its simulation of human milk or its suitability
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`as a complete or partial substitute for human milk.” 21 U.S.C. § 321(z).
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`18.
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`Subject to an exemption described below, the Act deems infant formulas
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`adulterated if they are not made in compliance with FDA’s current good manufacturing practice
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`(“CGMP”) requirements for infant formulas established by regulation. See 21 U.S.C.
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`§§ 350a(a)(3) and 350a(b)(2); 21 C.F.R. §§ 106.1(a) and 106.5(b).
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`19.
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`FDA promulgated CGMP regulations for infant formulas at 21 C.F.R. Part 106,
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`Subpart B (“Infant Formula CGMP Regulations”). These regulations are designed to ensure the
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`safety of infant formula and prevent the manufacture of adulterated infant formula, and they
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`require manufacturers to implement a system of controls to cover all stages of manufacturing.
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`Infant Formula CGMP Regulations contain requirements for specific controls including, but not
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`limited to, controls to prevent adulteration of infant formula from microorganisms. See Interim
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`Final Rule, Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors,
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`Notification Requirements, and Records and Reports, for Infant Formula. 79 Fed. Reg. 7934,
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`7935 (Feb. 10, 2014); see also Final Rule, Current Good Manufacturing Practices, Quality
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`Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for
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`Infant Formula. 79 Fed. Reg. 33,057 (June 10, 2014).
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`20.
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`In conjunction with Infant Formula CGMP Regulations, FDA also promulgated
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`requirements for record-keeping, including a requirement that manufacturers have procedures for
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`handling all written and oral complaints (“Infant Formula Record Requirements”). See 21
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`U.S.C. § 350a(b)(4); 21 C.F.R. § 106.100(k). Under Infant Formula Record Requirements,
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`manufacturers must conduct an investigation when a complaint shows a possible health hazard.
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`The failure to comply with Infant Formula Record Requirements, including the requirement for
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`complaint-handling procedures, renders infant formulas adulterated within the meaning of 21
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`U.S.C. § 350a(a)(3). See 21 C.F.R. §§ 106.1(c) and 106.100(r).
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`Exempt Infant Formula
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`21.
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`The Act exempts certain infant formulas from several aspects of 21 U.S.C.
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`§ 350a—the specific provision of the Act governing the manufacture and adulteration of infant
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`formula—including provisions relating to compliance with Infant Formula CGMP Regulations
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`and Infant Formula Record Requirements. See 21 U.S.C. § 350a(h) (providing exemption from,
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`among others, the requirements in 21 U.S.C. §§ 350a(a)(3), 350a(b)(2), and 350a(b)(4)). The
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`exemption applies to infant formula “which is represented and labeled for use by an infant—(A)
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`who has an inborn error of metabolism or a low birth weight, or (B) who otherwise has an
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`unusual medical or dietary problem.” 21 U.S.C. § 350a(h)(1). This type of product is known as
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`an “exempt infant formula.” FDA promulgated regulations that establish conditions with which
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`a manufacturer must comply to obtain and retain this exemption. See 21 U.S.C. §§ 350a(h)(1)
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`and 350a(h)(2); 21 C.F.R. § 107.50.
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`22.
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`Inborn errors of metabolism are rare, inherited (genetic) disorders in which the
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`body cannot properly turn food into energy. They are caused by defects in specific proteins
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`(enzymes) that help break down (metabolize) certain nutrients in food. These disorders result in
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`the buildup of toxic compounds in the brain and other important organ systems, and they can
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`cause a wide range of medical problems. Several inborn errors of metabolism are life-
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`threatening and known to cause severe and permanent brain damage and associated problems
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`such as developmental delay, movement disorder, and/or coma. Infants with inborn errors of
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`metabolism cannot tolerate certain nutrients (e.g., certain amino acids) found in infant formulas;
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`therefore, these infants need specialty infant formulas to meet their nutritional needs to support
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`and promote growth while avoiding the offending nutrient(s). Other types of disorders requiring
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`specialty infant formulas are severe allergies where infants cannot tolerate proteins that are not
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`broken down and require alternate types of infant formulas, such as amino acid-based formulas.
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`23.
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`This Complaint refers to the exempt infant formulas that Defendants manufacture
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`at AN-Sturgis as “the Specialty Infant Formulas,” and the non-exempt infant formulas that
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`Defendants manufacture at AN-Sturgis as “the Standard Infant Formulas.” The Specialty Infant
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`Formulas are intended to address inborn errors of metabolism, such as maple syrup urine disease
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`(“MSUD”), urea cycle disorders (“UCD”), and glutaric aciduria type 1 (“GA-1”), and other
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`conditions, such as severe food allergies.
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`24. Microbiological contamination of any infant formula, including the Specialty
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`Infant Formulas and the Standard Infant Formulas, can have devastating and potentially deadly
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`effects on vulnerable infants.
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`Food, Generally
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`25.
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`Under the Act, all infant formulas are “food” (see definition of “infant formula”
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`above) and, therefore, are subject to the Act’s requirements applicable to food.
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`26.
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`“Food” is adulterated within the meaning of the Act “if it has been prepared,
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`packed, or held under insanitary conditions whereby it may have become contaminated with
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`filth, or whereby it may have been rendered injurious to health.” 21 U.S.C. § 342(a)(4).
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`27.
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`Food manufacturers must adhere to FDA’s current good manufacturing practice
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`regulations (“CGMP Regulations for Human Food”), codified at 21 C.F.R. Part 117, Subpart B,
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`which establish basic practices that must be followed and conditions that must be maintained
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`during food manufacturing operations. See 21 C.F.R. §§ 117.10 through 117.110.
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`28.
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`CGMP Regulations for Human Food require, among other things, that
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`manufacturing conditions and practices protect against contamination of food and food-contact
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`surfaces from any source. See generally 21 C.F.R. Part 117, Subpart B.
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`29.
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`The failure to comply with CGMP Regulations for Human Food renders food
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`adulterated within the meaning of 21 U.S.C. § 342(a)(4). See 21 C.F.R. § 117.1(a)(1)(ii).
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`30.
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`The Specialty Infant Formulas, the Standard Infant Formulas, and the other food
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`that Defendants manufacture at AN-Sturgis are required to be made in compliance with CGMP
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`Regulations for Human Food. The Standard Infant Formulas are also required to be made in
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`compliance with Infant Formula CGMP Regulations.
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`Violations of the Act
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`31.
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`The Act, 21 U.S.C. § 331(a), prohibits introducing into interstate commerce:
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` (a) Articles of food, namely infant formulas as defined in 21 U.S.C. § 321(z),
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`that are adulterated within the meaning of 21 U.S.C. § 350a(a)(3) in that they have been
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`processed in a manner that does not comply with current good manufacturing practice
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`requirements for infant formula set forth at 21 U.S.C. § 350a(b)(2) and 21 C.F.R. Part 106; and
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`(b)
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`Articles of food that are adulterated within the meaning of 21 U.S.C.
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`§ 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby
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`they may have become contaminated with filth or whereby they may have been rendered
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`injurious to health.
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`32.
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`The Act, 21 U.S.C. § 331(k), prohibits causing:
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`(a)
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`Articles of food, namely infant formulas as defined in 21 U.S.C. § 321(z),
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`that are held for sale after shipment of one or more of their components in interstate commerce to
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`become adulterated within the meaning of 21 U.S.C. § 350a(a)(3); and
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`(b)
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`Articles of food that are held for sale after shipment of one or more of
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`their components in interstate commerce to become adulterated within the meaning of 21 U.S.C.
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`§ 342(a)(4).
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`33.
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`The evidence gathered during FDA’s recent inspection at AN-Sturgis (described
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`below) demonstrates that Defendants adulterate food within the meaning of 21 U.S.C.
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`§§ 342(a)(4) and 350a(a)(3).
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`34.
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`The evidence also demonstrates that Defendants manufacture their products from
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`ingredients shipped to them in interstate commerce and distribute their adulterated food in
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`interstate commerce.
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`35.
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`Therefore, Defendants violate the Act by: (a) introducing into interstate
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`commerce articles of food that are adulterated within the meaning of 21 U.S.C. §§ 342(a)(4) and
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`350a(a)(3); and (b) causing articles of food that are held for sale after shipment of one or more of
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`their components in interstate commerce to become adulterated within the meaning of 21 U.S.C.
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`§§ 342(a)(4) and/or 350a(a)(3). See 21 U.S.C. §§ 331(a) and 331(k), respectively.
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`FDA’s 2022 Inspection at AN-Sturgis
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`36.
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`FDA conducted its most recent inspection at AN-Sturgis between January 31 and
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`March 18, 2022 (“2022 Inspection”). During the 2022 Inspection, FDA investigators
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`documented conditions and practices that fail to control microbiological growth within the food-
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`processing areas at AN-Sturgis.
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`37.
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`FDA’s inspectional findings from the 2022 Inspection establish that Defendants
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`lack adequate measures to ensure the safety and quality of the Specialty Infant Formulas, the
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`Standard Infant Formulas, and the powdered food for older children that Defendants manufacture
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`at AN-Sturgis. Among other things, Defendants use shared equipment for manufacturing their
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`products. As a result, these products are at risk of contamination from bacteria, such as C. sak.
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`38.
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`FDA investigators collected samples from surfaces in AN-Sturgis’s production
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`areas for powder infant formula. FDA laboratory analysis of those samples detected C. sak. on
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`several surfaces, including:
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`(a)
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`The cover of a scoop hopper, which is used to feed scoops that are placed
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`directly inside infant formula containers and come in contact with product. At the time the
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`sample from the scoop hopper cover had been collected, a batch of infant formula was being
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`packaged; and
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`(b)
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`A structural support and the immediately surrounding floor of a spray
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`dryer, and two areas in the dehumidification room on the fourth level of that spray-dryer tower,
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`i.e., the floor between a duct-taped spot and the wall, and the floor and seam of the first door. At
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`the time the samples on or near the spray dryer had been collected, the spray dryer was in a
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`cleaning cycle, which introduces water into this dry-production environment and the equipment
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`interiors.
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`39.
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`Additionally, Defendants’ own environmental samples between September 25,
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`2019, and February 20, 2022, confirmed the presence of Cronobacter spp. on surfaces in AN-
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`Sturgis’s production areas for powder infant formula.
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`40.
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`The 2022 Inspection also documented Abbott’s failure to control water in areas of
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`AN-Sturgis’s facilities that are intended to be used for processing powder infant formulas. The
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`uncontrolled wet environment in processing areas, in conjunction with the presence of C. sak.
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`and deteriorating equipment that enables harborage of C. sak. (i.e., cracks in food-contact
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`surfaces of equipment, as described below), create an unacceptable risk of bacterial
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`contamination of Defendants’ products.
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`41.
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`On January 31, 2022, FDA investigators observed water on several levels of a
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`spray-dryer tower, while the spray dryer was being used to process a batch of powder infant
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`formula, as follows:
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`(a)
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`On the tower’s fifth level, the investigators observed water on the floor
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`from a steam-condensate leak in the inlet steam coils; the water was dripping from the valves
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`onto the floor of the tower’s fourth level. FDA investigators noted that, according to
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`Defendants’ records, AN-Sturgis had prior water leaks (on January 21, 2022, November 4, 2021,
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`and February 1, 2021) associated with inlet steam coils;
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`(b)
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`On the tower’s second level, the investigators observed water around the
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`floor drain near the potassium hydroxide tanks, which are used for pH adjustment in the
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`production of powder infant formula, and at the floor-wall junction near the floor scrubber used
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`to clean the floors of the spray-dryer tower; and
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`(c)
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`On the tower’s basement level, the investigators observed water on the
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`floor by an eye-wash station, which is adjacent to the air-handling system of a vibratory fluid bed
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`used to further cool the powder infant formula as it comes out of the main chamber of the spray
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`dryer.
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`42.
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`FDA investigators observed that Defendants’ records documented a total of 310
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`water events, e.g., water leaks and condensation, at AN-Sturgis between January 1, 2020, and
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`February 1, 2022. Those water events occurred in dry-production areas for powder infant
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`formulas, e.g., during spray-drying the infant formula and/or filling the infant formula into
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`containers. Defendants’ records describe several water leaks as necessitating repairs of the AN-
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`Sturgis roof. When C. sak. is present in a manufacturing environment, it can be further spread to
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`other processing areas, particularly where water is poorly controlled.
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`43.
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`FDA investigators observed that Defendants had not validated the “dry-out” step
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`for their spray dryers to ensure that complete drying is achieved after water is introduced into the
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`spray-dryer environment during cleaning.
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`44.
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`FDA investigators observed that Defendants’ records documented a history of
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`internal deterioration of the spray dryers at AN-Sturgis, dating back to September 2018.
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`Defendants’ last spray-dryer inspection, which occurred in August 2021, showed damage
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`including, but not limited to, cracks and pits inside the dryers’ main chambers. This type of
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`damage creates the potential for niches and harborage sites for bacterial contamination to persist,
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`particularly in the presence of moisture.
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`45.
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`Additionally, FDA investigators observed that AN-Sturgis personnel (employees
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`or contractors) working in infant formula processing areas did not wear necessary protective
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`apparel to protect against contamination of infant formula. For example:
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`(a)
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`On January 31, 2022, FDA investigators observed an employee exit the
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`elevator in a spray-dryer tower and enter the room containing the vibratory fluid bed—and pass
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`the shoe sanitizing station without spraying the soles of his/her shoes with sanitizer. When this
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`inspectional observation was made, the nozzle of the sanitizer bottle was improperly set to
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`stream instead of spray, which does not allow a uniform coating of sanitizer on the shoe soles.
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`At the time the employee failed to sanitize his/her shoes, the spray dyer was processing a batch
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`of powder infant formula; and
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`(b)
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`Between January 31 and February 12, 2022, FDA investigators observed
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`that AN-Sturgis employees and contractors were not required to spray their “captive shoes” (i.e.,
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`shoes that are to be worn only inside the facilities) with sanitizer before entering the production
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`area. Part of that time (specifically, between January 31 and February 4, 2022, and February 8,
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`2022), FDA investigators observed that AN-Sturgis employees had been wearing their captive
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`shoes while walking in hallways and the cafeteria and exiting the restroom.
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`46.
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`Further, the investigators found that Defendants failed to follow their own
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`procedures to determine the root cause of consumer complaints associated with their products.
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`Specifically, FDA investigators reviewed Defendants’ complaint investigations for consumer
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`complaints received by FDA, identified as FDA Consumer Complaint Nos. 171222, 170177,
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`171771, 171087, that are associated with (but not definitively caused by) powder infant formulas
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`manufactured at AN-Sturgis, including reported C. sak. illnesses and a reported illness from
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`Salmonella newport. The FDA investigators found that Defendants closed their complaint
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`investigations without having identified a root cause for the reported illnesses associated with
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`bacterial infection.
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`47.
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`FDA investigators observed that, although Defendants’ standard operating
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`procedure (“Complaint Management and Investigations” v. 26, s. 5.2.2.8 on page 26) states that
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`retained samples are to be evaluated for microbial analysis when “there is a potential for the
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`distributed product not to comply with specifications,” Defendants closed their complaint
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`investigations without having evaluated any retained samples of the Consumer Complaint-related
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`powder infant formulas for microbiological contamination.
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`48.
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`At the close of the 2022 Inspection, FDA investigators issued a Form FDA-483,
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`List of Inspectional Observations (“FDA-483”), to Defendant TJ Hathaway and discussed the
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`FDA-483 observations with him.
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`Case 1:22-cv-00441-HYJ-SJB ECF No. 1, PageID.15 Filed 05/16/22 Page 15 of 21
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`Adulteration Based on Violations of CGMP Regulations for Human Food
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`49.
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`The evidence gathered during the 2022 Inspection establishes that Defendants
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`violate CGMP Regulations for Human Food. Among other requirements, Defendants do not
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`comply with the CGMP Regulations for Human Food set forth at 21 C.F.R. §§ 117.80(a)(1),
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`117.35(d), and 117.10(b), as described below.
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`50.
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`Defendants fail to conduct food manufacturing operations in accordance with
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`adequate sanitation principles, as required by 21 C.F.R. § 117.80(a)(1). Examples of this failure
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`are discussed in paragraph 41 (the presence of dripping water in Defendants’ spray-dryer tower)
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`and paragraph 42 (water leaks and condensation in various powder infant formula production
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`areas).
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`51.
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`The presence of C. sak. on the cover of a scoop hopper during packaging of a
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`batch of infant formula, as discussed in paragraph 38(a), adds to the risk of contamination posed
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`by uncontrolled water dripping, leaking, and condensing in production areas.
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`52.
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`Defendants fail to (a) ensure that food-contact surfaces of equipment that are wet-
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`cleaned are thoroughly dried before subsequent use, and (b) maintain food-contact surfaces,
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`including utensils and food-contact surfaces of equipment, used for manufacturing low-moisture
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`food (which includes powder infant formula) in a clean, dry, and sanitary condition before use,
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`as required by 21 C.F.R. § 117.35(d)(1). Examples of these failures are discussed in paragraph
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`43 (failure to validate the “dry-out” step for spray dryers, which means there is no assurance that
`
`complete drying is achieved after water is introduced during cleaning) and paragraph 44
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`(damage, such as cracks and pits, inside the spray dryers’ main chambers).
`
`53.
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`Defendants fail to ensure that personnel working in direct contact with food, food-
`
`contact surfaces, and food-packaging materials conform to hygienic practices including wearing
`
`
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`Case 1:22-cv-00441-HYJ-SJB ECF No. 1, PageID.16 Filed 05/16/22 Page 16 of 21
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`suitable outer garments to protect against contamination of food, food-contact surfaces, and
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`food-packaging materials, as required by 21 C.F.R. § 117.10(b)(1). Examples of this failure are
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`discussed in paragraph 45 (failure to sanitize footwear before entering production areas).
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`54.
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`Defendants’ violations of CGMP Regulations for Human Food render
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`Defendants’ products (including the Specialty Infant Formulas, the Standard Infant Formulas,
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`and the other food manufactured at AN-Sturgis) adulterated within the meaning of 21 U.S.C.
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`§ 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby
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`they may have become contaminated or been rendered injurious to health. See 21 C.F.R.
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`§ 117.1(a)(1)(ii).
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`Adulteration Based on Violations of Infant Formula CGMP Regulations
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`55.
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`The evidence gathered during the 2022 Inspection also establishes that
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`Defendants violate the Infant Formula CGMP Regulations and the Infant Formula Records
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`Requirements. Among other requirements, Defendants do not comply with the Infant Formula
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`CGMP Regulations set forth at 21 C.F.R. §§ 106.20(a), 106.55(a), 106.30(b), 106.10(b)(1), and
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`106.100(k)(2), as described below.
`
`56.
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`Defendants fail to maintain buildings used in the manufacture of infant formula in
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`a clean and sanitary condition, as required by 21 C.F.R. § 106.20(a). Examples of this failure are
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`described in paragraph 41 (the presence of dripping water in Defendants’ spray-dryer tower) and
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`paragraph 42 (water leaks and condensation in various powder infant formula production areas).
`
`57.
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`Defendants fail to have an adequate system of process controls covering all stages
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`of processing that is designed to ensure that infant formula does not become adulterated within
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`the meaning of the Act (21 U.S.C. §§ 342(a)(4) and 350a(a)(3), among others) as a result of the
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`presence of microorganisms in the formula or in the processing environment, as required by 21
`
`
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`Case 1:22-cv-00441-HYJ-SJB ECF No. 1, PageID.17 Filed 05/16/22 Page 17 of 21
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`C.F.R. § 106.55(a). Examples of this failure are described in paragraph 38 (C. sak. detected in
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`the processing environment) and paragraph 39 (Cronobacter spp. detected in the processing
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`environment).
`
`58.
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`Defendants fail to ensure that all surfaces of equipment and utensils that contact
`
`raw ingredients, in-process materials, or infant formula are cleaned, sanitized, and maintained in
`
`a manner that protects infant formula from being contaminated by any source, as required by 21
`
`C.F.R. § 106.30(b). Examples of this failure are described in paragraph 43 (failure to validate
`
`the “dry-out” step for spray dryers, which means there is no assurance that complete drying is
`
`achieved after water is introduced during cleaning) and paragraph 44 (damage, such as cracks
`
`and pits, inside the spray dryers’ main chambers).
`
`59.
`
`Defendants fail to ensure that personnel working directly with infant formula,
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`infant formula raw ingredients, infant formula packaging, or infant formula equipment or utensil
`
`contact surfaces, conform to hygienic practices, including wearing suitable outer garments, to
`
`protect infant formula against contamination, as required by 21 C.F.R. § 106.10(b)(1). Examples
`
`of this failure are discussed in paragraph 45 (failure to sanitize footwear before entering
`
`production areas).
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`60.
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`Defendants fail to conduct an adequate investigation into the validity of a
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`complaint that shows that a health hazard possibly exists. Specifically, Defendants’ complaint
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`investigations do not document a determination whether a health hazard