FAIRFIELD, CALIF. — The US Food and Drug Administration (FDA) on Feb. 21 issued a warning letter to Primal Pet Foods, Inc., regarding inspections of the company’s Fairfield facility between July 14 and Oct. 11. The inspections were conducted in response to a recall of Primal’s Raw Frozen Primal Patties for Dogs Beef Formula on July 6, 2022. The voluntary recall, which involved a single lot of product, was made due to potential Listeria monocytogenes contamination.

In the February warning letter, the FDA witnessed “significant violations” of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulations. These violations include a lack of supporting documentation to identify and implement certain preventive controls for raw and freeze-dried pet food manufacturing, specifically for controlling pathogens.

“During the inspection, your firm provided finished product microbial test results for cat and dog food manufactured between August 2021 [and] August 2022 showing 49 products tested positive for Listeria monocytogenes or Salmonella spp,” the FDA stated in the letter. “These positive results demonstrate the controls you have identified are not effectively and significantly minimizing or preventing the hazard of pathogens.”

Additionally, the FDA assessed Primal Pet Foods’ corrective actions to ensure proper vitamin D3 levels to be insufficient. A sample of the company’s Canine Turkey & Sardine Formula Freeze Dried, which was distributed on April 22, 2021, contained elevated levels of vitamin D3. Primal Pet Foods’ corrective actions policy in SOP-722 states, “If the levels of vitamin D exceed the requirements, the product will be destroyed.” However, the diet was distributed before lab results came back to the company, “making it impossible for you to have destroyed the food in accordance with SOP-722,” the FDA stated in the letter.

The company was also found to have insufficiently managed thiamine deficiency hazards in its cat food, based on AAFCO Food Nutrient Profiles for thiamine in feline diets. The company distributed one lot of its Feline Chicken & Salmon Formula Freeze Dried formulas on Jan. 11, 2021, with thiamine levels of 3.96 mg/kg based on dry weight, which falls below the AAFCO minimum level of 5.6 mg/kg.

Primal Pet Foods issued an official statement regarding the warning letter on March 15.

“Throughout last year’s inspection, our team partnered with FDA officials to review our existing food safety plan and identify opportunities to strengthen it,” the company stated. “The FDA was satisfied with our voluntary recall process and terminated the recall in late January 2023. As a follow up to the routine inspection, we also responded to a Warning Letter that the FDA issued to request additional information about specific aspects of our food safety plan.

“For example, we committed to start using HPP on all frozen red meat formulas as an added safety measure in addition to sourcing high-quality red meats, testing raw materials and testing and holding the finished product prior to distribution. We needed to show how we are consistently implementing this new procedure (like we’ve been doing effectively on frozen poultry formulas since 2011).

“We are confident we are taking the right steps to ensure we are continuing to make raw food even safer for our consumers and their pets.”

Read more about pet food safety on our Operations page.