Burkmann Industries Inc. – FDA Warning Letter, Jun 27, 2017
On August 29, 2017, the FDA issued a Warning Letter to Burkmann Industries Inc. following an inspection from June 2-27, 2017, at their Danville, KY facility. The inspection was prompted by a Reportable Food Registry (RFR) event on May 30, 2017, concerning the death of at least 23 cattle after consuming the firm's 2858 - WCN Balancer R1400 TZI product, which contained elevated Monensin levels.
The FDA found serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations. Specifically, the firm manufactured and distributed a medicated animal food (2858 - WCN Balancer R1400 TZI, lot 205087-3) with a superpotent concentration of Monensin (9070 grams per ton, 648% of labeled concentration). This rendered the product unsafe under section 512(a)(2)(A)(i) and adulterated under section 501(a)(6) of the FD&C Act.
The inspection also revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal food manufacturers (21 CFR Part 225), making the product adulterated under Section 501(a
ID · 4c3b7362-cf99-4022-815d-e6703fe4c249
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