FDA WARNING_LETTER - JBS Souderton, Inc. dba MOPAC - October 17, 2018

The FDA issued a Warning Letter to JBS USA Holdings, Inc. following an inspection of their rendering plant, JBS Souderton, Inc. dba MOPAC, from March to October 2018, in conjunction with the Pennsylvania Department of Agriculture. The plant produces animal food ingredients.

The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, rendering their products adulterated. Specifically, the firm violated FDA's Current Good Manufacturing Practice (CGMP) requirements for animal food (21 CFR part 507, subpart B, 507.4, and subpart F). A key violation was the failure to examine raw materials to ensure suitability for manufacturing, specifically not identifying and excluding ingredients containing pentobarbital (21 CFR 507.25(b)(1)).

Furthermore, FDA analysis confirmed the presence of pentobarbital in animal fat products, including pure tallow, making them adulterated as they contain an unsafe new animal drug without an established tolerance in edible animal tissues (Sections 402(a)(2)(C)(ii) and 512(a)(1) of the Act). Samples collected by FDA and PDA showed pentobarbital levels ranging from trace amounts to 680 ng/g.

Despite the firm's stated corrective actions, including refusing equine ingredients, supplier questionnaires, supplier guarantees, and comprehensive cleaning, a sample collected in August 2018 after these