FOOD SAFETY UPDATE Our Response to the FDA Warning Letter March 15, 2023 (Updated March 24, 2023). This is a minimally processed freeze-dried food formula devoid of any corn, wheat, soy, or fillers. The Dog Food Advisor first became aware of the warning on March 21, 2023. Pathogens in pet food can make people as well as pets sick. It is their responsibility to ensure their pet foods are safe before marketing them. If you have any follow up questions about our food safety plan, the content of the FDAs letter and/or our response, please contact us by phone at (800) 742-1312, MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting anonline request. FDA has determined that their facility is subject to the registration requirement in the FD&C Act10 and its implementing regulations. 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. If you bought a pet food that has an active recall, heres what you should do: As of this publish date, these are the active pet food recalls from 2022. You can find the lot number and best by date on the back of the food packaging. By signing up, you agree to our Privacy Policy. Primal Dog Food is a premium dog & cat food brand, a part of Primal Pet Foods established in 2001 by Matt Koss. 3. This inspection was conducted in response to a Class 1 recall initiated on July 6, 2022, of Raw Frozen Primal Patties for Dogs Beef Formula, lot number W10068709, due to the presence of Listeria monocytogenes detected in an FDA surveillance sample. We appreciate your continued support of the Primal Pet Foods brand and our mission to introduce more dogs and cats to the benefit of raw and fresh food. The Minnesota Department of Agriculture flagged the health risk after a routine state surveillance sample. Why it was recalled:Sunshine Mills recalled some dog food products because of the possibility that it contains excessive levels of aflatoxin. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Sources: 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. We worked closely with the FDA inspectors to review our existing food safety plan and identify enhancements to both policies and processes. Luckily, at the time of the recall, no complaints or illnesses had been reported. In your Hazard Analysis at the Mix Supplements and Veggies step, you 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 your testing prerequisite program. They also conduct a test and hold procedure for all their products to ensure that they are free of harmful bacteria. Due to the raw nature of the formulas, there is much concern about the safety quotient of the diet, especially against harmful bacteria such as, They also conduct a test and hold procedure for all their products to ensure that they are free of harmful bacteria. Why it was recalled: Real Pet Food recalled 4-pound bags of Billy+Margot Wild Kangaroo And Superfoods after routine sample testing found salmonella in this product. 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. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. Continue with Recommended Cookies, The Honest Kitchen Dog Food Reviewed: Pros, Cons, and Ingredient Analysis, CBD for Dog Anxiety: Top 11 Products According to a Veterinarian, The Best Probiotics For Dogs in 2022 According to a Veterinarian, The Best Cat Food for Indoor Cats: Our Top 7 Picks, CBD for Cat Anxiety: Our Top 5 Picks + Reviews, The Farmers Dog Food Reviewed: Pros, Cons, and Ingredient Analysis, Ollie Dog Food Reviewed: Pros, Cons, and Ingredient Analysis, Open Farm Cat Food Reviewed: Pros, Cons, and Ingredient Analysis, By Katelyn Son | Updated February 28, 2023. fda.gov Common symptoms can range from mild to severe and include: Even if your dog seems fine, you should still talk to your vet if your pup ate some of the recalled product because he can still be a carrier for the bacteria and pass it on to you or other animals. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. Just for Fun. Sportmix. The firm failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required. Perry Animal Clinic | Perry | Michigan | Vet | Pet Clinic | Veterinarian | Veterinary | Small Animal |, Pet Oral Care Products Market Size worth US$ 3.21 Billion by 2031 | CAGR: 6.6% TMR Study, Is There A Recall On Royal Canin Dog Food 2021, What Brands Of Dog Food Did The Fda Recall. Their production process involves adding a quantity of (redacted) ppm PAA into their pet food. Primal Pet Foods is committed to the quality and safety of its products. Why it was recalled: Primal Pet Foods recalled 6-pound packages of the beef formula of their raw frozen Primal Patties For Dogs due to possible listeria contamination. These positive results demonstrate the controls you have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. Shop at an Online RetailerGet 30% Off + Free Shipping, Copyright 2023 Dog Food Advisor All Rights Reserved, If a pet parent has product from this lot in their possession, they should, FDA Investigating Potential Link Between Diet and Heart Disease in Dogs, Raw Frozen Primal Patties for Dogs Beef Formula. Affected products are 2-pound rolls from lot GA1102. Were only including recalls that are still active, which means there can still be risks associated with using that product. 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. You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1). If you have purchased the product you should immediately discard the product and stop feeding it to your dogs. The significant violations are as follows: Hazard Analysis and Risk-Based Preventive Controls Requirements. Your animal food facility is subject to the Hazard Analysis and Risk-Based Preventive Controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During our inspection of your facility, the FDA Investigator observed evidence of significant violations of these requirements including, but not limited to, the following: 1. The. 2. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide supporting documentation to demonstrate these corrections have been completed and are being consistently implemented. If your pet has been eating this food and shows signs of discomfort or illness please contact your veterinarian immediately. a) The lab report numbered 21-124-9881 with a sample received date of April 23, 2021, for the product Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) reported Vitamin D3 levels, based on dry weight, as 3,410 IU/kg. The United States Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 535 Watt Drive, Suite B, Fairfield, CA 94534-1790 from July 14 through October 11, 2022. You can also email Primal Pet Foods INC at support@primalpetfoods.com, call 1-866-566-4652 EXT. 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. Tesco is the. Your pets deserve better. Thank you. You identified (b)(4) as the preventive control for frozen products and probiotic inclusion as the preventive control for freeze dried products. Our recipes are cooked sous vide style in convenient, ready-to serve packages for a great new way to add fresh food to your pet's diet. 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. Primal Pet Foods is voluntarily recalling a single lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound), with best by date of 05/22/23, due to potential contamination with . Listeria reportedly rarely causes illness in dogs, but if they are ill, it can cause symptoms like diarrhea and vomiting. found 100,170 to 107,282 IU/kg of vitamin D in your canned dog food. Our Raw Frozen Primal Patties should be kept frozen until a pet parent is ready to use them. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Primal Pet Foods, Inc. - 645467 - 02/21/2023, https://www.fda.gov/media/110477/download, https://www.fda.gov/media/113923/download. We break down what a pet food recall actually is, what to do about it, and all the pet foods that have been recalled in the past five years (plus, why that matters). Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. This makes Primal Dog Food a safe, To ensure that you make the best and safest choice for your dogs daily meals, we have reviewed and analyzed the most popular Primal Dog Food formulas you can find on Amazon &, Minimally processed raw food with optimum nutrient levels, Contains lamb, which is a source of high protein, Contains superfoods like blueberries, pumpkin, and carrots. Your written response should be directed to: Sergio Chavez Matt tried feeding his dog a diet made of bones and raw food, and it saved his dog from renal failure. Your preventive controls for the hazard of pathogens were found to be ineffective; therefore, you 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. The recall states that the food was produced outside of our grind size specification of 1/8 which we have determined is the ideal size of ground bone to be fed to dogs and cats. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. The lot number and best by date can be found on the lower third of the back of the Raw Frozen Primal Patties package. According to Food Safety News, Primal Pet Foods voluntarily recalled 396 units of Raw Frozen Primal Patties for Dogs Beef Formula because it was potentially contaminated with listeria. Violations resulted in the issuance of an FDA Form 483. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. 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. U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area. We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. Primal Dog Food makes several product lines. Well send you our daily roundup of all our favorite stories from across the site, from travel to food to shopping to entertainment. According to a news release from the U.S. Food & Drug Administration, the Fairfield, California-based company is recalling a single lot of Raw Frozen Primal Patties for Dogs Beef Formula. Raw food is the most appealing food for dogs as they are carnivores by nature. If you were affected by this recall, an excellent alternative is The Farmer's Dog. While the nutrient tests that the FDA noted were technically out of compliance, the slight variance was not a health concern for pets. Darla R. 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