FDA EIR - Hill's Pet Nutrition Inc - February 19, 2019

The FDA conducted a full-scope Preventive Control and Low Acid Canned Food inspection at Hill's Pet Nutrition Inc. in Topeka, KS, from February 1 to February 19, 2019. This inspection, following a directed recall, was guided by the regulatory framework of 21 CFR Part 507. The primary violation, documented in an FDA-483 *Inspectional Observation*, was the company's failure to implement preventive controls to significantly minimize hazards. Specifically, Hill's Pet Nutrition Inc. did not adhere to its food safety plan, which required analytical testing for high-risk chemical hazards like ingredient misformulation, prior to unloading. This oversight resulted in the use of a vitamin premix containing roughly 30 times the acceptable limit of Vitamin D3 in pet food products.

This critical issue led to a recall of millions of cases of canned dog food globally and was associated with 85 reported pet deaths. Management indicated immediate corrective actions, including requiring a Certificate of Analysis with every vitamin premix shipment and conducting third-party lab testing for verification. Additionally, the inspection highlighted minor issues regarding documentation precision, product identification on seam tear-down records, and dated Quality Control signatures. Management was advised to provide a formal written response to the observation within fifteen days, underscoring their responsibility for compliance with the FD&C Act. The main observation was noted as "Not Corrected" at the time of the report.