FDA WARNING_LETTER - All American Coop - September 09, 2013

An FDA and MDA inspection of All American Cooperative, a licensed medicated feed mill, was conducted in September 2013, following a Reportable Food Registry (RFR) incident. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 225), causing medicated feeds to be adulterated under section 501(a)(2)(B) of the Act. The RFR incident involved the erroneous commingling of medicated swine feeds due to equipment malfunction, which was later mistakenly substituted into dairy feeds and fed to lactating dairy cows, rendering them unsafe and adulterated under sections 512(a)(2) and 501(a)(6) due to unapproved drug combinations. Additionally, the firm is not registered as a drug establishment (section 510(j)), causing all medicated feeds to be misbranded (section 502(o)). Certain feeds were also misbranded (section 502(f)(1)) due to inadequate labeling directions. Specific CGMP violations included employees lacking understanding of operations, equipment failing to ensure intended potency/safety/purity, Master Record Files lacking labeling, inadequate medicated feed labeling, and failures in proofreading and discarding outdated labels. The firm must promptly correct these violations and establish preventative procedures. A written response detailing corrective actions and timelines is required within 15 working days. Failure to comply may result in regulatory sanctions, including seizure, injunction, or withdrawal of the Medicated Feed Mill License.