FDA WARNING_LETTER - Evans Farms Feed - December 09, 2021

On April 21, 2022, the FDA issued a Warning Letter to Mr. John E. Evans, owner of an animal food manufacturing facility in Alvin, Texas, following an inspection from November 30 to December 9, 2021. This inspection was prompted by an October 26, 2021, consumer complaint regarding multiple horses falling ill, with one death, after consuming the facility's feed. Private testing indicated fumonisin levels in the implicated horse food, and follow-up testing by the Office of the Texas State Chemist confirmed elevated levels. Fumonisin levels exceeding 1.0 ppm are known to cause liver disease and fatal nervous system damage in horses.

The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation (21 CFR Part 507), rendering the products adulterated. Specifically, the facility failed to prepare and implement a written food safety plan, as required by 21 CFR 507.31, which must include a hazard analysis, preventive controls, a supply-chain program, a recall plan, and written procedures for monitoring, corrective actions, and verification. The owner admitted to not having a food safety plan.

Additionally, the firm failed to evaluate and use raw materials susceptible to mycotoxin contamination in a manner that prevents injury or illness, as required by