FDA 483 - Midwestern Pet Foods Chickasha Operation - February 05, 2021

This FDA Form 483 documents observations from an inspection related to the manufacture of pet food containing corn and corn products. The primary issue identified is the failure to implement and maintain adequate preventive controls for aflatoxin and Salmonella spp.

Regarding aflatoxin, the facility identified it as a hazard requiring a preventive control, with an acceptance parameter of (b)(4) for incoming corn. However, finished pet food products, including SportMix Premium High Energy dog food and SportMix Original Recipe cat food, from various lot codes (0303202S138162, 0303202S138164, 0429202S138163, 0429202S) were found to have total aflatoxin levels ranging from 21.5 ppb to 558 ppb, exceeding the acceptable level and confirming levels greater than (b)(4) in distributed products. The preventive control for aflatoxin at receiving, involving on-site sample collection and analysis, was not properly implemented. The SOP for Aflatoxin Testing (dated 8/17/18 and an undated draft effective 8/25/20) required specific reagents ((b)(4) and (b)(4) respectively) for sample preparation, which were not consistently used, leading to inaccurate test results.

For Salmonella spp., the hazard analysis incorrectly identifies