FDA WARNING_LETTER - Cargill Incorporated - June 11, 2019

On January 27, 2020, the FDA issued a Warning Letter to Cargill, Inc. following an inspection of their animal food manufacturing facility in Cleveland, NC, from June 4-11, 2019. The inspection was a follow-up to a voluntary recall of multiple animal foods due to aflatoxin levels exceeding FDA action levels.

The inspection revealed violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), rendering products adulterated. Additionally, violations of CGMP for medicated feeds (21 CFR Part 225) were found, causing Southern States Traditions Chick Start & Grow to be adulterated. The firm also failed to report a reportable food to the Reportable Food Registry (RFR) within 24 hours.

Key violations include: 1. **Insufficient Hazard Assessment:** Failure to sufficiently assess the probability of aflatoxin occurrence without preventive controls, evidenced by numerous samples exceeding FDA and internal action levels. The firm's reliance on prerequisite programs was ineffective. 2. **Failure to Reanalyze Food Safety Plan:** The firm did not reanalyze its food safety plan after multiple notifications of elevated aflatoxin levels from December 2018 to April 2019, despite an unanticipated food safety problem and the plan's ineffectiveness. A reanalysis was required before changing suppliers.