FDA WARNING_LETTER - Brookhurst Mill - March 18, 2014

An FDA inspection of Brookhurst Mill, a licensed medicated feed mill, conducted from March 3-18, 2014, revealed significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 CFR 225), rendering manufactured medicated feed adulterated. The inspection also found that the medicated feed "Gamebird Grow" was misbranded under 403(a)(1) due to lower amprolium levels (0.014%) than labeled (0.025%). Furthermore, the new animal drug (amprolium) was deemed unsafe and adulterated because its use and labeling did not conform to drug approval, as it was labeled for game birds at a concentration only approved for chickens or turkeys. Key cGMP violations included failure to implement corrective actions for 13 out-of-specification assay results since April 2009 (21 CFR 225.58(d)), continued distribution of medicated feed after failing drug potency requirements (21 CFR 225.58(e)), and inadequate Master Record Files lacking essential manufacturing instructions, mixing steps, and sampling procedures (21 CFR 225.102(b)(1)(iv), (v)). Additionally, the firm failed to submit required drug assay failure reports to the FDA (21 CFR 510.301(a)(2)). The FDA requires a written response within fifteen working days detailing corrective actions and prevention strategies. Failure to comply may result in regulatory sanctions, including seizure, injunction, or withdrawal of the Medicated Feed Mill License.