GREELEY, Colo. – JBS S.A. said the company is cooperating with the US Food and Drug Administration (FDA) in efforts to correct problems at the company’s MOPAC rendering plant in Souderton, Pennsylvania.

“MOPAC is committed to the safety of our products and regulatory compliance,” the company said in a statement. “We are working with FDA on the issues raised in the letter and will review and enhance our procedures as necessary to ensure we continue to meet all quality and safety standards.”

In a warning letter dated April 23, 2019, FDA said an inspection found that the plant violated Current Good Manufacturing Practice requirements for animal food. The company, FDA said, had failed to examine raw materials and other ingredients to ensure the items were suitable for making animal food. The agency found some tallow products were contaminated with pentobarbital sodium which is approved for anesthetizing certain animals. The investigation also revealed that MOPAC continued to distribute the adulterated products after receiving formal notifications from a customer in February 2013 and the Pennsylvania Dept. of Agriculture on April 5, 2018.

“Specifically, our investigation found that you failed to identify and exclude raw materials and ingredients containing pentobarbital,” the letter stated. “For example, your firm did not conduct testing on raw materials other than grease. In March, during the investigation, you indicated you implemented several changes to attempt to gain more information about your suppliers and control over your incoming ingredients. These actions included refusing to receive equine ingredients, having your suppliers complete a questionnaire about their food safety practices, having suppliers sign guarantees that they do not pick up euthanized animals, and excluding suppliers that could not meet these new requirements.”

The warning letter notes that JBS told FDA about corrective actions taken at the Souderton plant. But subsequent inspections by FDA and the Pennsylvania Dept. of Agriculture revealed trace amounts of pentobarbital.

On Aug. 8, 2018, FDA asked JBS about holding, recalling or notifying customers about the contaminated animal food products. JBS offered to remove any contaminated and to have their tank cleaned. For customers that accepted the offer, JBS said the company removed the product and cleaned the tanks.

In November, JBS wrote to FDA describing the company’s withdrawals and attempted withdrawals of contaminated product from customers.

“We are unable to assess your corrective action because you have not implemented a voluntary recall or otherwise provided documentation demonstrating all contaminated products were removed from the marketplace,” FDA said in its warning letter. “It is your responsibility to recall or otherwise provide assurance that the product is not further distributed in the marketplace.”