FDA WARNING_LETTER - Lea-Way Farms Inc. dba Blue Ridge Beef - October 25, 2019

The FDA issued a Warning Letter to a raw pet food manufacturing facility in Statesville, NC, following an inspection from September 30 to October 25, 2019. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (21 CFR Part 507), resulting in adulterated pet food due to insanitary conditions. Key violations included failure to examine raw materials, improper plant construction, inadequate thawing procedures, insufficient precautions against contamination during operations, poor maintenance of holding/conveying systems and equipment, and physical facilities not in good repair. Additionally, plumbing was not designed to prevent contamination. Microbiological testing confirmed contamination with Salmonella, E. coli, and Listeria monocytogenes in in-process and finished products. The facility's food facility registration was also canceled, a prohibited act under the FD&C Act. Furthermore, the firm was found to be adding an unapproved animal food additive, (b)(4), to its pet food, which constitutes adulteration. While some corrective actions like product destruction and improved receiving procedures were noted, the firm's overall response lacked sufficient detail and timeframes for long-term compliance. The FDA requires a written response within fifteen working days detailing corrective actions, emphasizing the need for a robust food safety system, hazard analysis, and preventive controls to avoid further legal action and reinspection fees.