FDA EIR - Bravo Packing, Inc. - January 10, 2012

Bravo Packing, Inc., a New Jersey-based manufacturer of animal feed and pet products, underwent an FDA surveillance inspection on January 10, 2012. The inspection, conducted under the Bovine Spongiform Encephalopathy (BSE) Inspection Program and Ruminant Feed Ban Rule (CPGM 7371.009), aimed to assess compliance with animal feed safety regulations, referencing Guidance for Industry #195. Key issues identified included the firm's persistent lack of comprehensive record-keeping for undocumented calves, usually under 30 months old, found on their property. Although these animals were subsequently sent to a renderer and not processed into distributed products, the absence of formal receipt and processing records was a noted concern. Additionally, the firm lacked formal, written recall procedures, and an annual Cattle Material Prohibited from Animal Feed (CMPAF) agreement with their renderer was found to be incomplete compared to previous inspections. In response, Bravo Packing's management committed to establishing written recall procedures and implementing improved record-keeping for all animal receipts. They also indicated plans to install gates to deter unauthorized animal drop-offs. No immediate regulatory actions were taken, with no FDA Form 483 issued during the inspection.