Yesterday, March 28, 2022, FDA announced that a New Jersey District Court has entered a consent decree of permanent injunction against Bravo Packing, Inc., a New Jersey animal food manufacturer, and two of its owners and operators, Joseph Merola and Amanda Lloyd . See also Department of Justice (DOJ) Press Release.
It is the first consent decree of permanent injunction that has been entered against an animal food manufacturer for violating the current good manufacturing practice (CGMP) requirements for animal food in 21 CFR, Part 507. FDA had inspected the company’s facilities in 2019 and 2021 and found insanitary conditions, CGMP violations, and samples of finished product which tested positive for Salmonella and Listeria monocytogenes. FDA also issued a warning letter in 2020 in response to the findings in its 2019 inspections.
DOJ, which litigates on behalf of FDA, filed a complaint on March 15, 2022, alleging that Defendants had introduced adulterated food into interstate commerce. The consent decree reflects a negotiated injunction, which avoids the need for litigation over the terms of the injunction. The decree prohibits Defendants from receiving, preparing, processing, packing, holding, labeling, and / or distributing pet food unless and until the company completes corrective actions, and also provides FDA with other enforcement tools if Defendants fail to comply.
Although FDA usually seeks voluntary corrective actions, this case is a reminder that the Agency may pursue more forceful judicial remedies for serious and / or repeat violations. More specifically, FDA’s Regulatory Procedures Manual states that the Agency will favor an injunction when: (1) There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical; (2) There are significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or (3) There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through voluntary or other regulatory approaches.
© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 88