Between August 2021 and August 2022, Primal Pet Foods, Inc.’s internal finished product testing program found forty-nine (49) pathogen-positive finished product samples, according to a Warning Letter released this week by the U.S. Food and Drug Administration (FDA).
Primal Pet Foods, Inc. (Primal) is a manufacturer of raw frozen and raw freeze-dried dog and cat foods, toppers, and treats based in Fairfield, California.
On July 6, 2022, Primal announced a recall of a single production lot of Raw Frozen Primal Patties for Dogs, Beef Formula (Lot #W10068709) after routine sampling by the FDA found Listeria monocytogenes in the product.
As a follow-up to the recall, the FDA visited the company’s Fairfield manufacturing facility on July 14, 2022, to begin an inspection that continued until October 11th.
During the course of the inspection, FDA investigators documented a large number of troubling issues
What the FDA found
The failures summarized in the Warning Letter and on the FDA Inspections Database include problems with preventive controls, supplier verification, record keeping, and inadequate monitoring.
Preventative controls that did not prevent pathogens
Primal’s food safety program includes adding a probiotic to its freeze-dried products as a preventative control for Salmonella.
Probiotics are so-called “good” bacteria found in the digestive system. They play an important role in digestion and also help to prevent pathogens from taking up residence in the large intestine.
When the FDA reviewed Primal’s documentation purporting to validate the effectiveness of the probiotic, they found significant flaws in the validation study, including the use of a relatively insensitive method for detecting residual Salmonella.
The FDA maintains a zero-tolerance policy for Salmonella and other pathogens in all pet foods, and the standard method used by government and industry labs is able to find a single living Salmonella cell in 25 grams of sample. Yet the method used by Primal’s lab to support their validation study was only able to find Salmonella if it was present at a level of 10 or more Salmonella cells per gram.
Furthermore, the company offered no evidence that its probiotic control would have any effect at all on other pathogens, such as Listeria monocytogenes or E. coli O157:H7.
As further proof that the probiotic control was not working, the FDA cited Primal’s own records of 49 pathogen-positive production lots over a one-year period. An average of just under one contaminated batch per week.
Inadequate response to contaminated and out-of-compliance products
Primal’s standard operating procedure specified a maximum level for Vitamin D of 3000 International Units per kilogram (IU/kg). Yet the company shipped a batch of freeze-dried dog food containing 3410 IU/kg–more than 10% above the maximum specified level. And it did so before the sample of this batch even reached its third-party lab for testing.
Primal’s standard operating procedure also specified a minimum level for thiamine–an essential vitamin for cats–of 5.6 mg/kg in its feline diets. Yet the company shipped a batch of freeze-dried cat food containing only 3.96 mg/kg. Again, the product was shipped even before the sample reached the lab.
Primal found Salmonella and/or Listeria monocytogenes in its finished products on 49 occasions during a one-year period, according to the company’s own records. There is no information in the Warning Letter as to what happened to those 49 contaminated production batches.
The only publically announced product recall occurred as a result of the FDA having found Listeria monocytogenes in a routine surveillance sample.
After learning of the FDA’s findings, the company issued a public recall. Yet it took no steps to evaluate the safety of other pet foods manufactured on the same production line immediately before and after the recalled batch.
Unhelpful response to records requests
Primal did not promptly provide all required records when requested to do so by the FDA investigator, impeding the ability of the FDA to complete its inspection and evaluation in a timely fashion.
It is unclear from the limited information available in the Warning Letter and the FDA Inspections Database whether or not the company eventually supplied all of the requested documentation.
What happens next?
The Warning Letter was dated February 21, 2023.
The company was been given the standard fifteen (15) working days following receipt of the letter in which to respond in writing with specific steps taken to correct the list of violations, including copies of related documentation to support its corrective measures.
The ball is now in Primal’s court.
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