FDA WARNING_LETTER - Bartlett Cooperative Association - Bartlett Feed Mill - March 24, 2021

The FDA inspected an animal feed manufacturing facility in Bartlett, Kansas, from March 11-24, 2021, following a Class I recall of cattle feed linked to 87 cattle deaths. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal feed manufacturers (21 CFR Part 225), causing medicated and non-medicated feeds to be adulterated under Sections 501(a)(2)(B) and 402(a)(2)(C)(ii) of the FD&C Act.

Specifically, the facility manufactured a custom cattle feed with a super-potent concentration of monensin (approximately 616 g/ton), exceeding the maximum approved concentration of 400 g/ton for growing beef cattle (21 CFR 558.355(f)(3)(vi)). This made the feed unsafe and adulterated under Section 512(a)(2)(A) and 501(a)(6) of the FD&C Act.

Additionally, the distributed feed was misbranded under Section 502(a)(1) of the FD&C Act because its labeling falsely stated a monensin concentration of 45 g/ton and provided feeding directions (2.3 to 8.8 lbs/head/day for 50-200 mg/head/