FDA WARNING_LETTER - Sunshine Mills, Inc. - September 01, 2021

The FDA inspected Sunshine Mills, Inc.'s pet food facility in Tupelo, MS, from July 19 to September 1, 2021, following a March 2021 regulatory meeting. 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), which can lead to adulterated food under the FD&C Act.

The facility had five product recalls between August 2020 and July 2021 due to Salmonella and aflatoxin contamination. Violations included failure to implement preventive controls for mycotoxins in grain, evidenced by a finished product testing at 32.7 ppb aflatoxin, and improper mycotoxin testing procedures (e.g., not grinding samples, not assessing/adjusting water activity). The firm's sanitation preventive control for Salmonella was ineffective, with Salmonella Johannesburg found in a retail sample and Salmonella spp. on a compressed air nozzle in a post-lethal treatment area.

The company failed to implement appropriate corrective action procedures, as demonstrated by the distribution of aflatoxin-contaminated product despite out-of-specification test results. Corrective action procedures also lacked steps to evaluate affected product for safety and prevent its entry into commerce after positive environmental indicator organism swabs.

CGMP violations included failure to maintain food contact surfaces (frayed/pitted rubber, rust/corrosion on buckets,