The Food and Drug Administration has vetoed a proposal by Evanger’s Dog & Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for the animal euthanasia drug pentobarbital.

The proposal was revealed in a June 29 warning letter issued by FDA, and posted on its website Tuesday.

The letter, addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “serious violations of the Federal Food, Drug, and Cosmetic Act and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all recalled product.

The warning letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food, which had been fed to all five dogs, revealed the presence of a “large quantity” of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, IL, on Jan. 10.

On Feb. 14, the FDA inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

  • Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12-ounce can with the Lot #1816E06HB13;
  • Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12-ounce can with the Lot #2415E01ATB12 and BEST DEC 2019 date code;
  • Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat;
  • Pitted, cracked and damaged floors;
  • Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing; and
  • Inadequate temperature controls.

In addition to the two pentobarbital-positive samples cited in the Feb. 14 Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

  • Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020;
  • Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020;
  • Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020;
  • Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020; and
  • Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3 Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated Feb. 2 and 21, April 4, and May 18 and 23 this year, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the June warning letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat. However, Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.” FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated. FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products. But FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

The FDA also warned the owners of Evanger’s that the agency is aware that some individuals at Evanger’s are involved in the operation of two other pet food companies, which FDA did not name.

“We note that the new CGMP and hazard analysis and risk-based preventive controls requirements would also apply to any manufacturing, processing, packing, or holding of animal food by these firms unless an exemption applies,” according to the warning letter.

The warning letter concludes with a requirement that Evanger’s must furnish a written reply within 15 working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

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