Farmers Coop Co – FDA Warning Letter, Mar 30, 2012

On March 29 and 30, 2012, the FDA inspected Farmers Cooperative Company's medicated feed mill in Hospers, Iowa. The inspection revealed two violations of the Federal Food, Drug, and Cosmetic Act.

Firstly, the company used SAFE-GUARD 0.5% [fenbendazole] Type B medicated feed to manufacture Type C medicated feed for sheep/lambs. Fenbendazole is not approved for use in animal feed for sheep/lambs, and SAFE-GUARD 0.5% is labeled only for swine, beef, dairy, and horses. This unapproved use caused the medicated feed to be unsafe under section 512(a)(2)(A)(i) and adulterated under section 501(a)(6) of the FD&C Act.

Secondly, the company failed to provide labels for bulk medicated feed distributed to customers, violating 21 CFR § 225.180, which requires adequate labeling for all medicated feed deliveries. This deviation from Current Good Manufacturing Practice (CGMP) regulations (21 CFR §§ 225.120 – 225.202) caused the medicated feeds to be adulterated under section 501(a)(2)(B) of the FD&C Act.

Farmers Cooperative Company must take prompt action to correct these violations and establish procedures to prevent recurrence