In new report, FDA says Midwestern failed to “identify and implement preventive controls”

The Canine Review has obtained a devastating inspection report with details about what investigators uncovered at one of two Midwestern Pet Foods, Inc. manufacturing facilities in Chickasha, Oklahoma. On December 30, the FDA announced that Midwestern was recalling a selection of its Sportmix-brand dog and cat foods  (the list of products the company has recalled has since been expanded twice) following at least 28 dog deaths due to aflatoxin poisoning–though it soon became clear that the death count was significantly higher.

The report, also referred to as an FDA Form 483, was completed days ago by the FDA and obtained by TCR through a Freedom of Information Act request. The report notes that the company’s preventive controls “failed to adequately control the hazard of aflatoxin in your firm’s finished pet food products as evidenced by the following deficiencies…” The report goes on to list alarming concentration levels of aflatoxin in food samples taken from “multiple sources in Missouri.” 

Here’s an excerpt describing what the inspectors saw:

“You did not evaluate each known or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack or hold in your facility….Specifically, your hazard analysis does not identify or evaluate all reasonably foreseeable hazards in the raw materials you routinely receive, store, and use as ingredients in your extruded pet food products….”

FDA investigators initiated their inspections of the Evansville, Indiana-based pet food company on December 31, 2020, hours after the FDA announced what would become one of the deadliest pet food recalls in the country’s history (and the deadliest pet food aflatoxin recall, surpassing even the 2005-2006 Diamond Pet Foods aflatoxin recall) in a matter of days, at more than 110 dog deaths as of mid-January by the FDA’s count.

Midwestern is now facing a wave of class-action lawsuits on behalf of owners of dogs that were poisoned. 

TCR has also learned that, until this recent inspection, the Oklahoma facility was last inspected by an FDA “state partner” on Sept. 13, 2018, and that the inspection report produced from that inspection, according to an officer in the FDA’s Division of Information Policy Disclosure, was unremarkable.

In a conversation about the inspection report, FDA Center for Veterinary Medicine spokeswoman Anne Norris referred TCR to the FDA’s Investigator’s Operations Manual which lists out what’s involved in FDA’s establishment inspections. Norris and CVM have not yet commented about what, if anything, pet owners and consumers should take away from the report, nor have they shared steps, if any, CVM is taking to prevent what occurred from happening again.

Midwestern Pet Foods, Inc. CEO Jeffrey Nunn did not immediately comment when asked about the report.

The full report is provided for readers here: