FDA WARNING_LETTER - Midwestern Pet Foods Chickasha Operation - February 05, 2021

The FDA, along with the Oklahoma Department of Agriculture, inspected Midwestern Pet Foods' Chickasha, OK facility from December 31, 2020, to February 5, 2021, following a Class I recall for aflatoxin and numerous consumer complaints. Samples of SPORTMiX products showed aflatoxin levels as high as 558 ppb, rendering them adulterated. An inspection at the IL facility also led to a recall for Salmonella-positive results. The inspections revealed significant violations of 21 CFR Part 507, including the failure to identify or implement effective preventive controls for aflatoxin and Salmonella, as required by 21 CFR 507.34(a)(1). Specifically, the firm's aflatoxin testing procedures were inadequate, and Salmonella-positive pet food lots were distributed. Additionally, the firm failed to conduct a hazard analysis for known or reasonably foreseeable mycotoxins like vomitoxin and fumonisin in incoming grains at its OK, IN, and IL facilities (21 CFR 507.33(a)). At the NY and IN facilities, the firm failed to verify environmental pathogen preventive controls through consistent and effective environmental monitoring, as required by 21 CFR 507.49(a)(3), with inadequate swabbing and lack of documented corrective actions after positive results. The FDA noted that submitted corrective action plans lacked sufficient supporting documentation for full evaluation. The firm must respond within fifteen working days with specific corrective steps and documentation to prevent recurrence, or face potential legal action.