Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 1 of 18 PageID: 1
`
`BRIAN M. BOYNTON
`Principal Deputy Assistant Attorney General
`Civil Division
`ARUN G. RAO
`Deputy Assistant Attorney General
`GUSTAV W. EYLER
`Director
`Consumer Protection Branch
`ALLAN GORDUS
`Assistant Director
`NOAH T. KATZEN
`Trial Attorney
`Consumer Protection Branch
`Department of Justice, Civil Division
`P.O. Box 386
`Washington, D.C. 20044
`202-305-2428
`noah.t.katzen@usdoj.gov
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`
`
`UNITED STATES OF AMERICA,
`
`Plaintiff,
`
`v.
`
`BRAVO PACKING, INC., a corporation, and
`JOSEPH MEROLA and AMANDA LLOYD,
`individuals,
`
`
`Defendants.
`
`
`
`
`
`
`
`Case No. 22-cv-1380
`
`
`
`
`
`
`
`COMPLAINT FOR INJUNCTION
`
`Plaintiff, the United States of America, on behalf of the United States Food and Drug
`
`Administration (“FDA”), by and through its undersigned attorney at the United States
`
`Department of Justice’s Consumer Protection Branch, alleges:
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 2 of 18 PageID: 2
`
`1.
`
`This statutory injunction proceeding is brought under the Federal Food, Drug, and
`
`Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), to halt the manufacture and distribution of
`
`adulterated raw animal food products. FDA laboratory testing has revealed that Defendants’ raw
`
`animal food is contaminated with the pathogen Salmonella, a health risk to animals and humans,
`
`and FDA inspections have shown that Defendants’ manufacture their raw animal food under
`
`grossly insanitary conditions. Plaintiff seeks an injunction to restrain and enjoin Defendants from
`
`directly or indirectly doing or causing the following acts:
`
`A.
`
`Violating 21 U.S.C. § 331(a), by introducing or delivering for introduction
`
`into interstate commerce articles of animal food that are adulterated: (1) within the meaning of
`
`21 U.S.C. § 342(a)(1) in that they bear or contain a poisonous or deleterious substance, namely
`
`Salmonella, which may render them injurious to health, and (2) within the meaning of 21 U.S.C.
`
`§ 342(a)(4), because they have been prepared, packed, or held under insanitary conditions
`
`whereby they may have become contaminated with filth, or whereby they may have been
`
`rendered injurious to health;
`
`B.
`
`Violating 21 U.S.C. § 331(k), by causing articles of animal food that are
`
`held for sale after shipment of one or more of their components in interstate commerce to
`
`become adulterated within the meaning of 21 U.S.C. §§ 342(a)(1) and (a)(4).
`
`JURISDICTION AND VENUE
`
`2.
`
`This Court has jurisdiction over the subject matter and all parties to this action
`
`pursuant to 28 U.S.C. §§ 1331, 1337, and 1345, and 21 U.S.C. § 332(a).
`
`3.
`
`Venue in this district is proper under 28 U.S.C. § 1391.
`
`
`
`
`
`
`
`2
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 3 of 18 PageID: 3
`
`THE PARTIES
`
`4.
`
`Plaintiff, the United States of America, brings this action on behalf of FDA, the
`
`agency mandated to protect the public health.
`
`5.
`
`Defendant Bravo Packing, Inc. (“Bravo”) is a corporation located at 59 N.
`
`Golfwood Ave., Carneys Point, New Jersey 08069, within the jurisdiction of this Court.
`
`
`
`6.
`
`Defendant Joseph Merola is the Owner and Secretary of Bravo. He has the duty,
`
`power, and authority to prevent, detect, and correct violations and hire and fire employees. He is
`
`responsible for recipe adjustments and maintains financial oversight over all purchases and
`
`equipment repair. Joseph Merola performs his duties at the Bravo facility, within the jurisdiction
`
`of this Court.
`
`7.
`
`Defendant Amanda Lloyd is the President of Bravo. Her primary responsibilities
`
`include managing product orders, ordering supplies, and overseeing accounting duties. She
`
`maintains Bravo’s receiving and shipping records. Ms. Lloyd performs her duties at the Bravo
`
`facility, within the jurisdiction of this Court.
`
`DEFENDANTS’ PRODUCTS
`
`
`
`8.
`
`Defendants manufacture, process, prepare, pack, hold, and distribute articles of
`
`food within the meaning of 21 U.S.C. § 321(f), namely raw animal food products.
`
`
`
`9.
`
`Bravo manufactures raw animal food products at its Carneys Point facility.
`
`Bravo’s animal food products include raw dog food and raw food for large exotic cats such as
`
`lions, tigers, and panthers.
`
`
`
`10.
`
`For their raw animal food products, Defendants grind their own beef, tripe, and
`
`trachea from cows that they slaughter on site. The ground beef, tripe, and trachea are then
`
`extruded into a mixer, where they are combined with other ingredients, including dehydrated egg
`
`
`
`3
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 4 of 18 PageID: 4
`
`powder and salted blood. The food is packaged in plastic bags, which are frozen before
`
`distribution.
`
`
`
`11.
`
`Defendants distribute their raw animal food products in interstate commerce to
`
`customers located in New York.
`
`
`
`12.
`
`Defendants receive a mineral mix used in their raw animal food products in
`
`interstate commerce from a supplier in Pennsylvania.
`
`HEALTH RISKS ASSOCIATED WITH DEFENDANTS’ PRODUCTS
`
`
`
`13.
`
`Defendants’ raw animal food products have continuously been found to contain
`
`the pathogen Salmonella, which is a health risk to humans and animals. Because Defendants’
`
`products are not intended to be cooked or subject to another type of preparation that would
`
`destroy any pathogens before being served to animals, the Salmonella in the raw animal food
`
`presents a significant public health risk to both animals and humans who handle the food and
`
`care for the animals. Salmonella can cause illness, called salmonellosis, in both humans and
`
`animals, and it is easily transferred from animal food to humans through handling, or from
`
`infected animals to humans.
`
`
`
`14.
`
`Salmonellosis in humans is typically associated with diarrhea, fever, and
`
`abdominal cramps that lasts 4 to 7 days. Although the symptoms usually resolve without
`
`treatment in healthy adults, salmonellosis can cause severe dehydration and lead to death without
`
`prompt treatment in certain populations, including infants, young children, the elderly, transplant
`
`recipients, pregnant women, and individuals with weakened immune systems. A small number
`
`of individuals with Salmonella infections develop reactive arthritis (i.e., arthritis from an
`
`immune reaction to the infection), which can lead to chronic arthritis. The Centers for Disease
`
`
`
`4
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 5 of 18 PageID: 5
`
`Control and Prevention (“CDC”) estimate that annually there are 1.35 million human cases of
`
`salmonellosis in the United States, with 26,500 hospitalizations and 420 deaths.
`
`
`
`15.
`
`Humans can become infected with Salmonella if they touch contaminated animal
`
`food and do not thoroughly wash their hands afterward. In addition, Salmonella in animal food
`
`can cross-contaminate human food if the animal food is stored or handled in common areas with
`
`human food, a regular practice among consumers.
`
`
`
`16.
`
`Dogs infected with Salmonella from contaminated animal food can exhibit
`
`symptoms such as vomiting, diarrhea, fever, loss of appetite, and/or decreased activity level. In
`
`some cases, the Salmonella infection may spread from the animal’s intestines to the blood
`
`stream, leading to death if not treated. However, infected dogs often do not appear to be sick
`
`after consuming food contaminated with Salmonella, but can still be carriers of Salmonella and
`
`spread the pathogen to their human owners.
`
`
`
`17.
`
`Any infected animal will shed Salmonella in its feces, and Salmonella can be
`
`transmitted to humans if they do not thoroughly wash their hands after cleaning up animal feces.
`
`Additionally, many animals groom themselves after they eat or defecate, and Salmonella can be
`
`transmitted from their mouths to surfaces that they subsequently lick, including a person’s face
`
`or hands. For example, if a pet plays with a toy immediately after eating food containing
`
`Salmonella, the pathogen could easily transfer to people who touch the toy and then their
`
`mouths; this scenario is very common with young children.
`
`REGULATORY FRAMEWORK
`
`
`
`18.
`
`Defendants’ raw animal food products are animal food within the meaning of the
`
`Act, 21 U.S.C. § 321(f).
`
`
`
`5
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 6 of 18 PageID: 6
`
`
`
`19.
`
`Animal food is adulterated if it bears or contain a poisonous or deleterious
`
`substance, such as Salmonella, which may render the animal food injurious to health. 21 U.S.C.
`
`§ 342(a)(1).
`
`
`
`20.
`
`Animal food manufacturers, like Defendants, that manufacture, process, pack, or
`
`hold food for consumption in the United States, and for which an exemption under 21 C.F.R.
`
`§ 1.226 does not apply, are required to register their facility with FDA under 21 U.S.C. § 350d.
`
`Registered animal food manufacturers are subject to FDA’s current good manufacturing practice
`
`(“CGMP”) regulations for animal food, which establish basic practices that must be followed,
`
`and conditions that must be maintained, to ensure that animal food is processed in a safe and
`
`sanitary manner. See 21 C.F.R. Part 507. The exemptions from registration for food
`
`manufacturing facilities under 21 C.F.R. § 1.226 include foreign facilities, farms, retail food
`
`establishments, restaurants, non-profit food establishments, fishing vessels, and facilities that are
`
`regulated exclusively by the United States Department of Agriculture. None of the exemptions
`
`in 21 C.F.R. § 1.226 apply to Defendants’ facility.
`
`
`
`21.
`
`Registered animal food manufacturers must monitor, with sufficient frequency,
`
`their sanitation conditions and practices used during processing to ensure, at a minimum, that
`
`they conform with the CGMP regulations for manufacturing, processing, packing, or holding
`
`animal food. See, e.g., 21 C.F.R. Part 507 subpart B; 21 C.F.R. § 507.5(a). Violations of CGMP
`
`help to determine whether the facilities, methods, practices, and controls used to process animal
`
`food are sanitary and safe. 21 C.F.R. § 507.1(a)(1)(ii); see also 21 C.F.R. Part 507.
`
`
`
`22.
`
`Failure to follow the animal food CGMP regulations renders the animal food
`
`adulterated within the meaning of 21 U.S.C. § 342(a)(4). See 21 C.F.R. § 507.1(a)(1)(ii).
`
`
`
`
`
`6
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 7 of 18 PageID: 7
`
`DEFENDANTS’ VIOLATIONS
`
`
`
`23.
`
`Defendants violate 21 U.S.C. § 331(a) by introducing or delivering for
`
`introduction into interstate commerce, or the causing thereof, animal food that is adulterated
`
`within the meaning of 21 U.S.C. § 342(a)(1) and 21 U.S.C. § 342(a)(4).
`
`
`
`24.
`
`Defendants violate 21 U.S.C. § 331(k) because they cause animal food held for
`
`sale after shipment of one or more components in interstate commerce to become adulterated
`
`within the meaning of 21 U.S.C. § 342(a)(1) and 21 U.S.C. § 342(a)(4).
`
`
`
`25.
`
`Defendants’ animal food products are adulterated within the meaning of
`
`21 U.S.C. § 342(a)(1) in that they bear or contain a poisonous or deleterious substance, namely
`
`Salmonella, which may render them injurious to health.
`
`
`
`26.
`
`Defendants’ animal food products are adulterated within the meaning of
`
`21 U.S.C. § 342(a)(4), because they have been prepared, packed, or held under insanitary
`
`conditions whereby they may have become contaminated with filth, or whereby they may have
`
`been rendered injurious to health.
`
`27.
`
`Defendants are required to register their facility because it manufactures,
`
`processes, packs, or holds food for consumption in the United States and an exemption under
`
`21 C.F.R. § 1.226 does not apply. See 21 U.S.C. § 350d; 21 C.F.R. § 1.225. Facilities that are
`
`required to register pursuant to 21 C.F.R. § 1.225 must comply with the CGMP requirements of
`
`21 C.F.R. Part 507. See 21 C.F.R. § 507.5(a). Defendants have registered their facility for the
`
`period 12/07/2020 - 12/31/2022. Because Defendants process animal food products without
`
`adhering to the CGMP regulations, the products are adulterated within the meaning of 21 U.S.C.
`
`§ 342(a)(4). See 21 C.F.R. § 507.1(a)(1)(ii).
`
`
`
`
`
`7
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 8 of 18 PageID: 8
`
`EVIDENCE OF VIOLATIONS
`
`
`
`28.
`
`Defendants have had multiple instances of positive Salmonella findings in
`
`samples taken by FDA of finished raw animal food products. In addition, Defendants have an
`
`extensive history of manufacturing raw animal food products under grossly insanitary conditions.
`
`Defendants’ insanitary conditions can result in Salmonella being transferred from one lot of raw
`
`animal food to another. For example, one lot of raw animal food can be cross-contaminated by
`
`Salmonella from another lot through insanitary processing equipment and from personnel that do
`
`not follow proper hygiene. Salmonella can also be introduced into the raw animal food from
`
`pests such as cats and mice that can access food processing areas. Defendants’ pattern of
`
`continuing violative conduct has been documented by FDA investigators during inspections on
`
`May 25- 28, 2021 (the “May 2021 inspection”); January 21, 2021 to April 7, 2021 (the “April
`
`2021 inspection”); and July 22, 2019 to August 6, 2019 (the “July 2019 inspection”).
`
`Presence of Pathogens at Recent Inspections
`
`
`
`29.
`
`Although FDA observed serious violations of CGMP at all inspections, as
`
`discussed below, FDA samples taken at the April 2021 and July 2019 inspections further
`
`revealed the presence of pathogens in Defendants’ finished raw pet food products and
`
`Defendants’ facility.
`
`
`
`30.
`
`FDA conducted the April 2021 inspection in response to a consumer complaint
`
`received by FDA on December 10, 2020, in which a non-profit group collected a sample of
`
`Defendants’ raw animal food product from a retailer in California and discovered Salmonella in
`
`the sample through private laboratory testing,
`
`
`
`31.
`
`FDA investigators collected multiple finished raw pet food product samples
`
`during the April 2021 inspection.
`
`
`
`8
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 9 of 18 PageID: 9
`
`
`
`32.
`
`Subsequent testing by FDA revealed the presence of Salmonella in two out of
`
`three finished raw pet food product samples from the April 2021 inspection.
`
`
`
`33.
`
`FDA investigators also collected finished raw animal food product samples at the
`
`July 2019 inspection.
`
`
`
`34.
`
`Subsequent testing by FDA revealed the presence of Salmonella in 2 out of 2
`
`finished raw pet food product samples from the July 2019 inspection.
`
`
`
`35.
`
`FDA investigators also collected environmental samples from the food processing
`
`areas of Defendants’ facility during the April 2021 inspection. Subsequent testing of the
`
`environmental samples by FDA revealed the presence of Listeria monocytogenes (“L. mono”).
`
`
`
`36.
`
`FDA testing also found L. mono in three out of three of the finished raw pet food
`
`product samples from the April 2021 inspection.
`
`
`
`37.
`
`Subsequent testing also revealed the presence of L. mono in 1 out of 2 finished
`
`raw pet food product samples from the July 2019 inspection.
`
`
`
`38.
`
`To determine whether insanitary conditions at Defendants’ facility facilitated the
`
`harborage of a strain of L. mono, FDA performed whole genome sequencing (“WGS”) analysis
`
`on the April 2021 and July 2019 inspectional samples. FDA uses WGS to determine the
`
`complete and unique DNA make-up of an organism which can reveal pathogens with matching
`
`genomic sequence profiles originating from the same source. WGS of the samples from April
`
`2021 and July 2019 showed that a resident strain of L. mono has been established in Defendants’
`
`facility.
`
`
`
`
`
`39.
`
`The presence of such a strain of L. mono is evidence that Defendants have failed
`
`to maintain a clean and sanitized facility and have created an ideal environment for dangerous
`
`pathogens to contaminate their raw animal food products.
`
`
`
`9
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 10 of 18 PageID: 10
`
`CGMP Violations at the Most Recent Inspection
`
`
`
`40.
`
`FDA conducted its most recent inspection in May 2021. The purpose of the May
`
`2021 inspection was to confirm that the Defendants implemented the corrective actions that they
`
`committed to make after the April 2021 inspection.
`
`
`
`41.
`
`During the May 2021 inspection, FDA investigators observed numerous
`
`deviations from the animal food CGMP regulations that were the same or similar to violations
`
`observed at previous inspections, including, but not limited to, the following:
`
`
`
`
`
`
`
`
`
`A.
`
`Defendants failed to maintain the buildings, structures, fixtures, and other
`
`physical facilities of their plant in a clean manner and in good repair to prevent animal food from
`
`becoming adulterated, in violation of 21 C.F.R. § 507.19(a). For example, as they did at the
`
`previous inspection in April 2021, the investigators observed deep depressions, holes, and
`
`cracks, all of which contained pools of bloody water, in the floors of all food processing areas,
`
`including the slaughter room, deboning room, processing room, deboning room cooler, and raw
`
`ingredient cooler. Bacteria thrive in moist areas such as pools of blood or water, increasing the
`
`risk for product contamination. In addition, FDA investigators observed that Defendants stored
`
`uncovered barrels of deboned meat, an ingredient in their raw animal food, directly beneath a
`
`metal beam and brackets covered with flaking rust.
`
`
`
`
`
`B.
`
`Defendants failed to ensure that animal food-contact and non-contact
`
`surfaces of utensils and equipment are cleaned and maintained and utensils and equipment stored
`
`as necessary to protect against contamination of animal food, animal food-contact surfaces, or
`
`animal food-packaging materials, in violation of 21 C.F.R. § 507.19(b). In addition, they failed
`
`to ensure that animal food-contact surfaces are cleaned and sanitized before use, in violation of
`
`21 C.F.R. § 507.19(b)(2). For example, FDA investigators observed that Defendants did not
`
`
`
`10
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 11 of 18 PageID: 11
`
`remove debris that had adhered to production equipment used in the deboning, grinding, mixing,
`
`in-process holding, and bagging operations for raw animal food. Instead, Defendants sprayed a
`
`sanitizer, which was not labeled to control all pathogens previously identified in the product and
`
`environment, including L. mono, onto the debris covered equipment. In addition, FDA
`
`investigators observed that Defendants did not clean the mixer prior to the production of ready-
`
`to-eat raw dog food. The mixer contained an unknown substance of pooled black liquid and
`
`white fat-like deposits along the bottom of its basin;
`
`
`
`
`
`C.
`
`Defendants failed to take effective measures to exclude pests from the
`
`manufacturing, processing, packing, and holding areas and to protect against the contamination
`
`of animal food by pests, in violation of 21 C.F.R. § 507.19(e). For example, FDA investigators
`
`observed cats sitting and urinating on uncovered barrels containing deboned meat that
`
`Defendants stored outside. Defendants subsequently used this deboned meat to produce raw dog
`
`food. In addition, despite Defendants’ claims following the April 2021 inspection that they
`
`would repair doors that cats used to enter the facility, FDA investigators saw multiple cats
`
`entering and exiting the deboning room through an open sliding door; and
`
`
`
`
`
`D.
`
`Defendants failed to take reasonable measures and precautions to ensure
`
`that all persons working in direct contact with animal food, animal food-contact surfaces, and
`
`animal food-packaging materials conform to hygienic practices to the extent necessary to protect
`
`against the contamination of animal food, in violation of 21 C.F.R. § 507.14(a). For example,
`
`FDA investigators observed Defendant Merola repeatedly spitting on the floor of the food
`
`processing area, a practice he had committed to ending during the April 2021 inspection.
`
`Additionally, although the Defendants installed a sanitizing footbath after the April 2021
`
`
`
`11
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 12 of 18 PageID: 12
`
`inspection, FDA investigators at the May 2021 inspection observed that the footbath was either
`
`not being used or being used incorrectly.
`
`CGMP Violations at Previous Inspections
`
`
`
`42.
`
` FDA investigators observed significant ongoing violations of the Act and the
`
`animal food CGMP requirements during the April 2021 and July 2019 inspections, and issued
`
`Forms FDA-483 at the conclusion of the inspections. The Form FDA-483s for both inspections
`
`included observations of the same types of deficiencies observed at the May 2021 inspection.
`
`
`
`43.
`
`At both previous inspections, FDA investigators observed numerous deviations
`
`from the animal food CGMP including, but not limited to, the following:
`
`
`
`
`
`A.
`
`Defendants failed to ensure all animal food manufacturing, processing,
`
`packing, and holding is conducted under such conditions and controls as are necessary to
`
`minimize the potential for the growth of undesirable microorganisms to protect against the
`
`contamination of animal food, in violation of 21 C.F.R. § 507.25(a)(8). For example, as
`
`discussed above, the numerous positive samples for Salmonella and L. mono collected from
`
`Bravo’s manufacturing environment and finished product samples during the April 2021 and
`
`July 2019 inspections strongly indicated that Bravo’s conditions and controls to minimize the
`
`potential for the growth of undesirable microorganisms to protect against the contamination of
`
`animal food were highly ineffective;
`
`
`
`
`
`B.
`
`Defendants failed to maintain their plant in a clean manner and in good
`
`repair to prevent animal food from becoming adulterated, in violation of 21 C.F.R. § 507.19(a).
`
`For example, at the April 2021 inspection, FDA investigators observed a mix of pooled blood
`
`and water in the depressions, holes, and cracks in the floors throughout the food processing
`
`areas. FDA investigators also observed employees dragging barrels containing raw ingredients
`
`
`
`12
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 13 of 18 PageID: 13
`
`across the blood-soaked floors in the raw ingredient cooler. In addition, at the July 2019
`
`inspection, FDA investigators observed condensate drip and ice buildup on cases of the finished
`
`raw animal food product in one of the freezers;
`
`
`
`
`
`C.
`
`Defendants failed to ensure that animal food-contact and non-contact
`
`surfaces of utensils and equipment are cleaned and maintained and utensils and equipment stored
`
`as necessary to protect against contamination of animal food, animal food-contact surfaces, or
`
`animal food-packaging materials, in violation of 21 C.F.R. § 507.19(b). In addition, they failed
`
`to ensure that animal food-contact surfaces are cleaned and sanitized before use, in violation of
`
`21 C.F.R. § 507.19(b)(2). For example, during the April 2021 inspection, FDA investigators
`
`observed that Defendants did not clean or sanitize primary manufacturing areas, such as the
`
`deboning room and production rooms. In addition, as they did at the May 2021 inspection, FDA
`
`investigators observed that Defendants did not clean the product residue from equipment before
`
`processing food. Also, storage barrels that were purportedly “cleaned and sterilized” were found
`
`to contain diluted blood or other pooled liquid and remnants of meat. Similarly, during the July
`
`2019 inspection, FDA investigators observed several raw ingredient barrels containing black
`
`residue and pooled sanitizer after the Defendants cleaned the barrels; and
`
`
`
`
`
`D.
`
`Defendants failed to take effective measures to exclude pests from the
`
`manufacturing, processing, packing, and holding areas and to protect against the contamination
`
`of animal food by pests, in violation of 21 C.F.R. § 507.19(e). For example, FDA investigators
`
`observed multiple cats entering and leaving the deboning room at the April 2021 inspection.
`
`FDA investigators also observed cat feces in a corner of the deboning room. Defendant Merola
`
`stated that he cannot prevent the cats from entering the building. During the July 2019
`
`
`
`13
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 14 of 18 PageID: 14
`
`inspection, FDA investigators observed similar evidence of mice on cardboard boxes in a storage
`
`area; and
`
`
`
`
`
`E.
`
`Defendants failed to take reasonable measures and precautions to ensure
`
`that all persons working in direct contact with animal food, animal food-contact surfaces, and
`
`animal food-packaging materials conform to hygienic practices to the extent necessary to protect
`
`against the contamination of animal food, in violation of 21 C.F.R. § 507.14(a). For example,
`
`during the April 2021 inspection, FDA investigators observed employees stepping on
`
`manufacturing equipment food-contact surfaces while wearing boots that had not been cleaned or
`
`sanitized after leaving the food processing area. FDA investigators also observed Defendant
`
`Merola spitting chewing tobacco on the production floor, and an employee return from a toilet
`
`and smoke break without washing her hands before filling plastic bags with finished dog food.
`
`HISTORY
`
`
`
`44. Defendants have received ample notice that their manufacture of raw animal food
`
`violates the law and that continued violations could lead to regulatory action. At the close of the
`
`May 2021, April 2021, and July 2019 inspections, FDA investigators issued Forms FDA-483 to
`
`Defendants that notified them of the investigators’ observations. FDA investigators also
`
`discussed their observations with Defendants and encouraged them to make necessary
`
`corrections.
`
`
`
`45.
`
`In addition, following the July 2019 inspection, FDA sent Defendants a Warning
`
`Letter dated March 16, 2020, that detailed their CGMP violations.
`
`
`
`46.
`
`In response to the inspections and the Warning Letter, the Defendants have
`
`repeatedly promised, both orally and in letters to FDA, to bring their facility into compliance
`
`with regulatory requirements.
`
`
`
`14
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 15 of 18 PageID: 15
`
`
`
`47.
`
`Defendants are also aware of the danger that Salmonella contamination poses, as
`
`they have conducted voluntary full product recalls of their raw pet food products following the
`
`findings of Salmonella in their finished product samples in September 2019 and twice in March
`
`2021.
`
`
`
`50.
`
`Defendants have failed, however, to correct the insanitary conditions at their
`
`facility that have led directly to the Salmonella contamination in their finished products.
`
`
`
`51.
`
`Based on the foregoing, Plaintiff believes that, unless restrained by this Court,
`
`Defendants will continue to violate the Act in the manner set forth above.
`
`WHEREFORE, Plaintiff respectfully requests that this Court:
`
`PRAYER FOR RELIEF
`
`
`
`I.
`
`Order that Defendants, and each and all of their directors, officers, agents,
`
`representatives, employees, attorneys, successors, assigns, and any and all persons in active
`
`concert or participation with any of them, cease manufacturing, processing, preparing, packing,
`
`holding, or distributing articles of animal food, unless and until Defendants’ facilities, methods,
`
`processes, and controls used to manufacture, process, prepare, pack, hold, and distribute articles
`
`of animal food are established, operated, and administered in conformity with the Act and
`
`applicable regulations, in a manner acceptable to FDA; and
`
`
`
`II.
`
`Order that Defendants, and each and all of their directors, officers, agents,
`
`representatives, employees, attorneys, successors, assigns, and any and all persons in active
`
`concert or participation with any of them, be restrained and enjoined under 21 U.S.C. § 332(a)
`
`from directly or indirectly doing or causing to be done any of the following acts:
`
`
`
`
`
`a.
`
`Violating 21 U.S.C. § 331(a), by introducing or delivering for
`
`introduction, or causing to be introduced or delivered for introduction, into interstate commerce
`
`
`
`15
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 16 of 18 PageID: 16
`
`articles of animal food that are adulterated within the meaning of 21 U.S.C. §§ 342(a)(1) and
`
`(a)(4) ; and
`
`
`
`
`
`b.
`
`Violating 21 U.S.C. § 331(k), by causing articles of animal food that are
`
`held for sale after shipment of one or more of their components in interstate commerce to
`
`become adulterated within the meaning of 21 U.S.C. §§ 342 (a)(1) and (a)(4); and
`
`
`
`III.
`
`Order that FDA be authorized pursuant to this injunction to inspect Defendants’
`
`place(s) of business and all records relating to the manufacture, processing, preparing, packing,
`
`holding, and distribution of Defendants’ products to ensure continuing compliance with the
`
`terms of the injunction, and that the Defendants bear the costs of such inspections at the rates
`
`prevailing at the time of the inspection(s) are accomplished; and
`
`
`
`IV. Award Plaintiff costs incurred in pursuing this action, including the costs of
`
`investigation to date; and
`
`V.
`
`Order such other and further equitable relief as this Court deems just and proper.
`
`16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 17 of 18 PageID: 17
`
`Respectfully submitted,
`BRIAN M. BOYNTON
`Principal Deputy Assistant Attorney General
`Civil Division
`
`ARUN G. RAO
`Deputy Assistant Attorney General
`
`GUSTAV W. EYLER
`Director
`Consumer Protection Branch
`
`ALLAN GORDUS
`Assistant Director
`
`/s/ Noah T. Katzen___________________
`NOAH T. KATZEN
`Trial Attorney
`Consumer Protection Branch
`Department of Justice, Civil Division
`P.O. Box 386
`Washington, D.C. 20044
`202-305-2428
`noah.t.katzen@usdoj.gov
`
`
`Dated this 15th day of March, 2022.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`DANIEL J. BARRY
`Acting General Counsel
`Department of Health and Human Services
`
`PERHAM GORJI
`Deputy Chief Counsel for Litigation
`
`TARA BOLAND
`Senior Counsel
`Office of the Chief Counsel
`Food and Drug Administration
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`17
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 1 Filed 03/15/22 Page 18 of 18 PageID: 18
`
`DESIGNATION OF AGENT FOR SERVICE
`
`
`
`Pursuant to Local Rule 101.1(f), because the Department of Justice’s Consumer
`
`Protection Branch does not have an office in this district, the United States Attorney for the
`
`District of New Jersey is hereby designated as an alternative to undersigned counsel to receive
`
`service of all notices or papers in the captioned matter. Therefore, service upon the United States
`
`Attorney’s Office or its authorized designee:
`
`David E. Dauenheimer
`Deputy Chief, Government Fraud Unit
`United States Attorney’s Office
`District of New Jersey
`970 Broad Street, Suite 700
`Newark, NJ 07102-2534
`
`shall constitute service upon the United States for purposes of this action.
`
`Dated: March 15, 2022
`
`/s/ Noah T. Katzen______________
`NOAH T. KATZEN
`Trial Attorney
`Consumer Protection Branch
`Department of Justice, Civil Division
`P.O. Box 386
`Washington, D.C. 20044
`202-305-2428
`noah.t.katzen@usdoj.gov
`
`
`
`
`
`
`
`
`
`18
`
`