As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Primal Pet Foods
Fairfield, CA
An animal food firm in California is on notice from the FDA for serious violations of the FDA’s Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation, including Listeria found in the finished product. Pathogens in pet food can make people as well as pets sick.
In a Feb. 21 warning letter, the FDA described a July 14 through Oct. 11, 2022 inspection of Primal Pet Foods’ manufacturing facility in Fairfield, CA.
The inspection was conducted in response to a recall initiated on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula because of the presence of Listeria monocytogenes found in an FDA sample. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes.
The FDA’s inspection revealed that the firm was not in compliance with FDA regulations, specifically the FDA’s Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation.
These violations resulted in the issuance of an FDA Form 483.
The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls Requirements
1. The firm did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, as required.
Specifically, their firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. Their hazard analysis determined pathogens (Salmonella spp., Listeria monocytogenes, and E. coli O157:H7) are a hazard requiring a preventive control at the following steps: “Inbound Testing,” “Mix Probiotics, Supplements, and Veggies,” and “Outbound Testing.” Their food safety plan identified the following preventive controls for the hazard of pathogens: “Supply Chain: Approved Supplier,” “Probiotics,” and “Outbound Micro Testing.” During the inspection, the firm provided finished product microbial test results for cat and dog food manufactured between Aug. 2021- Aug. 2022 showing 49 products tested positive for Listeria monocytogenes or Salmonella spp. These positive results demonstrate the controls they have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. An indication the controls they implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample of their pet food, “Raw Frozen Primal Patties for Dogs Beef Formula,” collected from retail on May 24, 2022, resulting in the July 6, 2022, Class I recall.
2. The firm failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required.
Specifically, their reliance on their testing prerequisite program failed to reduce the probability that a nutrient deficiency or toxicity will occur in their pet food in the absence of a preventive control. In their Hazard Analysis at the “Mix Supplements and Veggies” step, they identified and evaluated the potential chemical hazard of the addition of Vitamin D and Thiamin as a significant hazard and determined it did not require a preventive control due to their testing prerequisite program. However, their prerequisite program was either insufficient or they failed to implement it adequately to manage the hazard.
3. The firm did not validate that the process preventive control they identified and implemented in accordance with regulation is adequate to control the hazard as appropriate to the nature of the preventive control and its role in their facility’s food safety system, as required.
Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. The FDA reviewed their validation study for the use of (redacted) as a preventive control for Salmonella in their freeze-dried beef products and we determined their validation study did not support their claim that the probiotic is an effective preventive control for Salmonella. The validation study did not report whether Salmonella was detected below (redacted) CFU/g. FDA considers even very small amounts of Salmonella in a pet food distributed to consumers to adulterate the food and preventive controls must ensure that animal food will not be adulterated. Also, their validation study does not address the other pathogens they have determined to be hazards requiring a preventive control, such as E. coli O157:H7 and Listeria monocytogenes.
4. The firm did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan, as required.
Specifically, on July 6, 2022, their firm recalled Raw Frozen Primal Patties for Dogs Beef Formula, lot W10068709, with a production date of (redacted), after an FDA surveillance sample of the lot revealed the presence of Listeria monocytogenes. The firm preventive controls for the hazard of pathogens were found to be ineffective; therefore, they are required to take corrective action to identify and correct the problem, reduce the likelihood the problem will recur, and evaluate all affected animal food for safety. During FDA’s inspection, FDA reviewed their “Grind Line Temperature Inspection” form for (redacted) line (redacted) indicated their firm manufactured (redacted) products before and (redacted) products after the recalled lot. The firm does not perform cleaning between batches of the same recipe and only performs a (redacted) when transitioning between different recipes. The firm failed to evaluate the safety of the products manufactured on the same date and line as the recalled lot. In addition, the firm failed to reduce the likelihood the problem will recur as evidenced by their testing showing four lots of finished product found positive for pathogens after implementation of their corrective actions in response to the recall.
The full warning letter can be viewed here.
Arrow Reliance Inc.
Tukwila, WA
An animal food firm in Washington is on notice from the FDA for not being in compliance with FDA regulations due to adulterated animal food, including finished products with Salmonella. Pathogens in pet food can make people as well as pets sick.
The U.S. Food and Drug Administration (FDA) collected samples of their Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwin’s Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats in response to a consumer complaint received about their products causing illness in the customer’s kittens. FDA laboratory analysis revealed these products to be contaminated with Salmonella.
Salmonella can affect animals eating the product and there is a risk to humans, notably children, the elderly and the immunocompromised, when handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or surfaces exposed to these products.
In a Feb. 16 warning letter, the FDA described an Aug. 23 through Sept. 30, 2022 inspection of Arrow Reliance Inc.’s pet food manufacturing facility in Tukwila, WA.
The FDA’s inspection revealed that the firm was not in compliance with FDA regulations because of adulterated animal food. Violations resulted in the issuance of an FDA Form 483.
The significant violations are as follows:
Adulterated Animal Food
On July 13, 2022, prior to the inspection of the firm’s facility, FDA collected and analyzed unopened samples of their Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9116, and Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats, lot 9121, from one of their customers after receiving a complaint from the customer that three kittens developed diarrhea after consuming the food. The complainant also provided documentation that a stool sample from one of the kittens tested positive for Salmonella spp.
FDA laboratory analysis of the sampled pet food products revealed the presence of Salmonella kentucky and Salmonella typhimurium in FDA sample 1179788, and Salmonella typhimurium in FDA sample 1179789. Additionally, during the inspection of their facility, FDA collected a sample of their Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9306, and FDA laboratory analysis revealed the presence of Salmonella typhimurium.
The Salmonella found in the three lots of pet food described above causes them to be adulterated because the Salmonella may render the food injurious to health.
Use of Peroxyacetic Acid (PAA)
FDA inspected the firm’s facility in June 2021, and subsequently sent them a letter dated Aug. 27, 2021, documenting our concerns with their use of PAA as a pathogen mitigation step to reduce E. coli O157:H7 and Salmonella spp. in their raw pet food products. In the FDA’s letter, FDA explained that any substances that may become part of their pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the FD&C Act, or should be otherwise not objectionable for use in animal food due to a definition in the AAFCO Official Publication.
During the current inspection, FDA Investigators noted they continue to use PAA as a pathogen mitigation step and they have increased their PAA concentration from (redacted) ppm to (redacted) ppm on the advice of their PAA supplier and a third-party laboratory. There is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Part 582 or 584 as a substance that is GRAS for the intended use. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. Under section 409(a) of the FD&C Act [21 U.S.C. § 348(a)(2)], an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated.
Although peroxyacids are permitted for use on certain meat products intended for human food as an antimicrobial secondary direct food additive under 21 CFR 173.370, the permitted uses allow for a maximum PAA concentration of 220 ppm. Additionally, the directions for use outlined on the label of the PAA product they use allow for a maximum concentration of 220 ppm of PAA on a ready-to-eat (cooked) human food. Their production process involves adding a quantity of (redacted) ppm PAA into their pet food. FDA is concerned that they have been unable to find scientific data indicating that PAA at that level is safe for dogs and cats to consume. It is their responsibility to ensure their pet foods are safe before marketing them.
Food Facility Registration
FDA has determined that their facility is subject to the registration requirement in the FD&C Act10 and its implementing regulations. FDA records indicate that as of the date of this letter, their facility is not registered with FDA.
In consideration as to whether their facility meets an exemption from the food facility registration requirement, FDA reviewed the definition of a “retail food establishment.” A “retail food establishment” sells food products from that establishment directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment’s primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. The firm’s Director of Quality informed FDA’s Investigators that the majority of their product (approximately (redacted) percent) is shipped directly to consumers from third-party warehouses rather than from their facility. Thus, their manufacturing facility is not a retail food establishment.
The full warning letter can be viewed here.
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