ATLANTA, GA. — The US Food and Drug Administration (FDA) issued a warning letter to Lea-Way Farms Inc. on June 26, citing “significant violations” of several animal food manufacturing policies at the raw pet food processor’s Statesville, N.C. facility.

The violations in question were observed during inspections conducted by the agency between Sept. 30 and Oct. 25, 2019.

The FDA reported violations to Current Good Manufacturing Practice (CGMP) requirements, including failure to properly inspect and handle raw materials, as well as unsanitary conditions in several areas of the plant.

Specifically, the FDA cited the use of raw animal ingredients “…that have died otherwise than by slaughter… without first determining whether the animals suffered any type of illness, injury, and/or whether any medications may have been administered to the animals prior to your pick up from the supplier…” The agency also observed the potential for contamination on the facility’s kill floor, grinder/mixing room, in the cooler, and in its overhead conveying rails between the kill floor, cooler room and processing area.

The company also failed to renew its food facility registration, which is a violation of the Food, Drug and Cosmetics (FD&C) Act. In its warning, the FDA requested a company official register the facility within 30 days of receiving the letter.

Additionally, the agency collected samples of finished product and raw ingredients from the plant, of which one sample of raw ground beef tested positive for a strain of Salmonella and another sample of Lea-Way’s Blue Ridge Beef Raw Kitten Grind tested positive for another strain of Salmonella and Listeria monocytogenes.

The contaminated kitten diet was disposed of before entering the market, according to the FDA. The agency also acknowledged Lea-Way had made improvements to its raw material handling procedures on Oct. 25 to ensure cattle products intended for use in pet food did not contain chemical residues or animal drugs.

Lea-Way made other corrective actions in November 2019, according to the FDA, including improving its environmental testing, thawing, sanitation and facility storage procedures, as well as improvements to product labeling, plumbing and waste management.

In the most recent letter, the FDA explained Lea-Way’s November 2019 response “…does not provide enough detail for us to evaluate whether your proposed corrective actions are sufficient to ensure long-term adoption of practices that will ensure your firm consistently meets CGMP requirements.” The agency plans to evaluate those corrective actions further upon its next inspection of the facility.

Read the comprehensive warning letter issued to Lea-Way Farms on June 26.

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