FDA EIR - Radagast Pet Food Inc - June 07, 2018

Radagast Pet Food, Inc., a raw cat food manufacturer in Portland, OR, underwent a comprehensive FDA inspection from May 22 to June 7, 2018. This inspection was initiated following a product recall after state samples tested positive for Listeria monocytogenes, and was also part of routine compliance checks for current Good Manufacturing Practices (CGMP) for animal food. The primary violation, documented on an FDA Form 483, concerned the firm's failure to maintain manufacturing conditions and controls adequate to prevent animal food contamination, as required by 21 CFR 507.25(a) of the Food, Drug, and Cosmetic Act. Specific issues included the detection of Listeria monocytogenes in an environmental swab from the processing plant and in a finished "Free-Range Turkey Recipe" product. Additionally, a non-O157 Shiga Toxin-producing Escherichia coli (STEC) was found in a "Pasture-Raised Venison Recipe" product. Investigations revealed the detected Listeria strain was identical to one from a prior 2016 recall, suggesting persistent contamination. In response, management immediately initiated a thorough cleaning of affected areas and re-testing. They committed to destroying the Listeria-positive turkey product and holding the STEC-positive venison product pending further testing. The company is investigating the source of contamination, including reviewing its High-Pressure Processing (HPP) methods, and plans to engage food safety consultants. They have also implemented routine finished product testing for Listeria and strengthened employee training on good manufacturing practices. Management plans to submit a written response detailing corrective actions within 15 business days.