FDA WARNING_LETTER - G & C Raw, LLC - May 17, 2019

The FDA conducted an inspection of a raw pet food manufacturing facility in Versailles, OH, from April to May 2019, identifying significant violations of the Current Good Manufacturing Practice (CGMP) regulations for animal food (21 CFR Part 507). These violations render the firm's raw pet foods adulterated, making their introduction into interstate commerce a prohibited act. Specific deficiencies included inadequate handling of work-in-process and rework (21 CFR 507.25(c)(3)), improper thawing of frozen ingredients leading to microbial growth (21 CFR 507.25(b)(3)), failure to ensure employee hygienic practices (21 CFR 507.14), and insufficient precautions in plant operations to prevent contamination (21 CFR 507.25(a)(5)). Evidence of these issues included the detection of Listeria monocytogenes in finished Raw Ground Turkey Dog Food and non-pathogenic Listeria species in environmental swabs. The letter also noted previous findings of Listeria monocytogenes and Salmonella spp. in 2018, indicating an ongoing problem. While the firm initiated recalls and provided a response outlining some corrective actions like ordering a sink and employee training, the FDA found the response insufficient due to a lack of detailed plans for long-term compliance and monitoring. The letter also reminded the firm of its requirement to implement hazard analysis and risk-based preventive controls (21 CFR Part 507, Subparts C and E) for pathogens like Salmonella and Listeria monocytogenes. The firm must provide a detailed written response within 15 working days, outlining specific corrective actions and prevention plans, or face potential legal action and reinspection fees.