FDA WARNING_LETTER - Lewiston Feed & Produce Company - December 17, 2020

The FDA conducted an inspection of Lewiston Feed and Produce Company on December 16-17, 2020, following reports of elevated monensin levels in a customer-formula medicated feed, batch code 619202, which led to multiple calf deaths from monensin toxicity. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) for Medicated Feeds (21 CFR Part 225).

The firm manufactured an adulterated medicated feed that was superpotent, containing 453.5 grams per ton of monensin, over ten times the approved amount for a Type C feed (10-40 g/ton), violating 21 CFR 558.355(f)(3)(ii). The product was also misbranded because its label lacked adequate directions for use, specifically mixing instructions, as required by section 502(f)(1) of the Act.

CGMP violations included the firm's failure to develop a complete master record file for the medicated feed, as mandated by 21 CFR 225.102(b)(1), which should include the correct formula, manufacturing instructions, and appropriate labeling. Additionally, the firm failed to label the feed with directions for use to ensure its safe and effective application, as required by 21 CFR 225.80(a). The firm verbally indicated plans to implement new software to prevent out-of-specification medicated feeds. Lewiston Feed and Produce Company must provide a written response to the FDA within 15 working days detailing corrective actions and preventative measures, with potential legal action for non-compliance.