FDA WARNING_LETTER - Templeton Feed & Grain Inc. - November 06, 2009

The FDA issued a Warning Letter to Templeton Feed & Grain Inc. following a November 3-6, 2009, inspection of their medicated feed mill in Templeton, California. The inspection revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations for Medicated Feed (21 CFR Part 225), causing their manufactured feed to be adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations included the firm's failure to perform periodic assays for medicated feeds (21 CFR 225.58(b)(1)) and a lack of investigation or corrective action for out-of-specification assay results (21 CFR 225.58(d)), both previously cited in a 2000 Warning Letter. The firm also lacked adequate inventory control procedures for drugs (21 CFR 225.42(b)) and failed to properly identify incoming Type A medicated articles (21 CFR 225.42(b)(1)). A critical finding was the mistaken use of sulfamethazine in feed labeled as sulfathiazole, leading to adulterated and misbranded feed (sections 512(a), 501(a)(5), 501(a)(6), and 403(a) of the Act). Additionally, this feed was mislabeled with an incorrect 7-day withdrawal period instead of the required 15 days. Templeton Feed & Grain Inc. must promptly correct these cGMP violations and establish recurrence prevention procedures. A written response detailing corrective actions and timelines is required within fifteen working days. Failure to comply may result in severe regulatory actions, including seizure, injunction, or withdrawal of their Medicated Feed Mill License.