Like some other dog food formulas, Primal Pet Foods says that their formulas closely imitate the diet of dogs in the wild. Office of Human and Animal Food Operations- West Division 5, CC: Matthew Koss, Founder/Chief Product Officer via email @ Matt@primalpetgroup.com. Additionally, we recognize that more education about this innovative approach to pathogen control is necessary and will be working to provide more information to you and your team. 3. If you have any questions about the steps we are taking, we encourage you to contact us by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting anonline request. Specifically, your firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. Their processing method is safe and complies with all USDA and. People can become sick by handling. When a pet food is recalled, its taken off the market by the U.S. Food and Drug Administration (FDA). During the FDA inspection, we provided a high-level summary from the third-party validation of the effectiveness of probiotics for safety. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes (both raw materials and finished product) before it left its production facility. b) Although you told the Investigator that you utilize the AAFCO Food Nutrient Profiles, the table on page 2 of your SOP-722 identified a minimum thiamine level of (b)(4) mg/kg based on a dry weight in feline diets. Primal Dog Food uses fresh and raw ingredients with minimal processing for its recipes. 4. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. 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. Texas Tripe Chicken, Pork And Salmon With Egg. No corn, wheat, soy, lentils, or legumes. 342(a)(4)] and 21 CFR 507.1(a)(1)(ii). The safety and quality of our products has always been my top priority. As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Through a recent product quality review process, we have determined that 5 specific Primal Canine and Feline Freeze-Dried Poultry Formulas were produced outside of our grind size . During FDAs inspection, our review of your Grind Line Temperature Inspection form for (b)(4) line (b)(4) indicated your firm manufactured (b)(4) products before and (b)(4) products after the recalled lot. The recall is only limited to food from a single lot. If your dog has consumed the Primal Pet Foods Raw Frozen Primal Patties for Dogs Beef Formula that has the product number #W10068709 and 05/23/23 listed as the best by date, you are encouraged to contact a veterinarian. Get Dog Food Recall . If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. Pathogens in pet food can make people as well as pets sick. Following our voluntary recall of a single lot of raw, frozen product last July, the FDA conducted a routine inspection of our Fairfield, California production facility. Excerpts from the Warning Letter indicate that two lots over the course of 12 months (Primal produces approximately 15,000 lots per year) were slightly outside of the AAFCO recommended nutrient profiles. Primal Dog Food is made in Fairfield, CA 94534, USA. Consumers: Primal Pet Foods 800-742-1312 Hazard Analysis and Risk-Based Preventive Controls Requirements. Throughout last years inspection, our team partnered with FDA officials to review our existing food safety plan and identify opportunities to strengthen it. The U.S. Food and Drug Administration (FDA) collected samples of their Darwins Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwins Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats in response to a consumer complaint received about their products causing illness in the customers kittens. If you have any questions, please view our recall FAQs or contact Primal Pet Foods by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. Thus, their manufacturing facility is not a retail food establishment. 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. Specifically, their firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. Dogs can have mild symptoms such as diarrhea and vomiting. The. The Dog Food Advisor first became aware of the warning on March 21, 2023. We have always routinely reviewed and updated our food safety programs to ensure that we meet or exceed all regulatory requirements as well as the nutritional efficacy of our foods as set forth by our Product Development and Nutrition Teams. (To sign up for a free subscription to Food Safety News, click here. 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. This letter notifies you of our concerns and provides you an opportunity to address them. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide adequate supporting documentation to demonstrate these corrections have been completed and consistently implemented. 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. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. If you have product from this lot in your possession, we ask that you stop feeding it to your dog and properly dispose of it. While not required from a regulatory standpoint, we have enhanced our nutritional testing to include a Test & Hold program. What's Being Recalled? The specific products recalled include the 15-ounce container and the 5-pound tub, both of which have expiration dates of November 20, 2022. According to the announcement from Top Quality Dog Food, anyone who received a package with that lot number should have been contacted already. This minimally processed blend of rich protein and healthy nutrients improves coat health, vision, and vitality in dogs. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 Monday-Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online form. The FDA reviewed your validation study for the use of (b)(4) as a preventive control for Salmonella in your freeze-dried beef products and we determined your validation study did not support your claim that the probiotic is an effective preventive control for Salmonella. Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. However, your prerequisite program was either insufficient or you failed to implement it adequately to manage the hazard. 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. 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. The validation study did not report whether Salmonella was detected below (redacted) CFU/g. You should take prompt action to correct any violations. According to the companys announcement, these issues are most likely associated with elevated levels of choline chloride in the food. Sportmix. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. Primal Dog Food Reviewed: Pros, Cons, and Ingredient Analysis. If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. In its recall notice, the company said the 66 cases396 bags of foodwere distributed . We have received no complaints or reports of illness to pets or humans from this lot. Do you use the whole apple including core and seeds in your formulas? Most recalls are voluntary your pet food company doesn't want to sell you contaminated food but some are enforced by the government. Summary: A Primal freeze-dried formula of delicious and easy-to-digest food topper. The main ingredient of this formula is cage-free, fresh, and organic beef. If a pet parent has product from this lot in their possession, they should stop feeding it to their dog and dispose of it immediately. The term retail food establishment includes facilities that manufacture, process, pack, or hold food if the establishments primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. Additionally, you added a sanitation preventive control, and you state training will be provided on the new procedures. Do Not Sell or Share My Personal Information. You did not identify and implement preventive controls to provide assurances that anyhazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1). Customers state that this is a high-quality food that has improved their dogs health substantially with consistent use. 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. The recipes use selected foods, making the ingredient list high-quality and transparent. This recall includes the following products: According to Sunshine Mills announcement, products with other lot codes werent affected and the company hasnt identified the cause of the salmonella exposure. As a result, your prerequisite program is insufficient to manage a thiamine deficiency hazard. Listeria reportedly rarely causes illness in dogs, but if they are ill, it can cause symptoms like diarrhea and vomiting. Your firm distributed the Feline Chicken & Salmon Formula Freeze Dried (lot W10022504) with a low thiamine level on January 11, 2021.Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have reworked the food in accordance with SOP-722, even if you had been aware of a low level of thiamine. From Balanced Bases to Toppers and Hydratorsexplore Primal Pet Foods to boost your dog or cat's meals for a happier and healthier life! If you bought the recalled product, you should stop feeding it to your dog and throw it away. We are unable to further evaluate this corrective action until we can review the final study report. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes . Specifically, on July 6, 2022, your firm recalled Raw Frozen Primal Patties for Dogs Beef Formula, lot W10068709, with a production date of (b) (4), after an FDA surveillance sample of the lot. The ingredients are carefully selected to make balanced meal recipes that improve dogs . Finally, your firm was not consistently testing the finished products for total Vitamin D (D2 and D3) levels, despite the fact that some of your ingredients contain Vitamin D2, which could contribute to elevated levels of Vitamin D in your dog food. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 Monday-Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. 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. Start your day with heartwarming and hilarious animal stories that will make you fall in love. 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. On July 13, 2022, prior to the inspection of the firms 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. Your response included a revised report of the validation study conducted by (b)(4) for the inhibition of Salmonella using (b)(4) with updated graphs and language. 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. July 6, 2022 Primal Pet Foods is recalling a single lot of Raw Frozen Primal Patties for Dogs Beef Formula due to potential contamination with Listeria monocytogenes bacteria. 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 & Chewy. Raw food is the most appealing food for dogs as they are carnivores by nature. The recall only applies to products that have lot codes 1081804 and 1082804, which were sold at Walmarts in Illinois, Missouri, Nebraska, New Mexico, Oklahoma, Utah, Wisconsin and Wyoming. The recalled products are: As of this publish date, theres only one active pet food recall from 2018. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. 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. 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. All the ingredients are organic, and the formula is free of any additives. Why it was recalled: Blue Ridge Beef issued a recall on its Kitten Grind raw pet food due to potential salmonella and listeria contamination. You can also report your complaint by visiting the FDA's " Report a Pet Food Complaint. 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. After a review of your revised validation study report, FDA still concludes your study does not support your claim that the probiotic is an effective preventive control for Salmonella in freeze dried, raw beef; therefore, your response is inadequate. This Primal recall is just one of over 39 recalls that have occurred in the past year. . Primal Pet Foods is committed to the quality and safety of its products. Like all Purina One True Instinct dog food recipes, this product relies on a high-quality animal protein source and a combination of healthy whole grains to supply starches and slow-release carbs. Program Division Director These violations resulted in the issuance of an FDA Form 483. For more information about FDAs current thinking on the requirements of 21 CFR Part 507, see: Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals https://www.fda.gov/media/97464/download We received your written response dated November 1, 2022. If a pet parent has product from this single lot (#W10068709) in their possession, they should stop feeding it to their dog and dispose of it immediately. The protein sources are organic and free of antibiotics, steroids, and hormones. While not required from a regulatory standpoint, we provided a high-level summary from the third-party validation of the on. You of our concerns and provides you an opportunity to address them prerequisite!, we have received no complaints or reports of illness to pets or humans from this lot, its off! High-Quality and transparent fresh, and vitality in dogs, but if they are,... 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