The site is secure. 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 2022 expansion of this recall now includes certain 2014 through 2020 Indian Heavyweight Air-Cooled Motorcycles, including the Chief, Chief Classic, Chief Dark Horse, Chief Vintage, Springfield. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. (According to the FDA, listeria infections arent too common in pets but can still happen.). 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. 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. 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. Be the first to know about special promotions, new products, and more! You may find the FD&C Act and FDAs regulations through links in FDAs home page at www.fda.gov. JUMP TO: Primal Pet Foods Primal Patties For Dogs (2022) | Freshpet Fresh From The Kitchen Home Cooked Chicken Recipe (2022) |Family Dollar pet food recall (2022) | Woody's Pet Food Deli recall (2021) |Top Quality Dog Food recall (2021) | Sunshine Mills dog food recall (2021) | Natural Balance cat food recall (2021) | Meow Mix cat food recall (2021) | Midwestern Pet Foods recall (2021) | Albrights Raw Dog Food recall (2020) | Real Pet Food dog food recall (2020) | Sunshine Mills dog food recall (2020) | Natural Balance cat food recall (2020) | Texas Tripe raw pet food recall (2019) | Blue Ridge Beef kitten food recall (2018). Exactly 66 cases of this product were distributed in April 2022 to these locations: No other Primal Pet Foods products or lot numbers are affected by this recall. 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. Specifically, your firm adds (b)(4) as a preventive control for pathogens for your freeze-dried products. Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. These positive results demonstrate the controls you have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. Why it was recalled: Rats were reported at a Family Dollar distribution center in West Memphis, Arkansas. The site is secure. No other products Purina products have been impacted by this recall. The two recalls were voluntary and didnt severely affect the health of any dogs. 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. 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. 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. By signing up, you agree to our Privacy Policy. 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. The letter was issued to the company on February 21, 2023 but was not made public by the FDA until March 14, 2023. Thank you. 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. This voluntary recall is a result of routine sampling by the U.S. Food and Drug Administration, which revealed a positive result for Listeria monocytogenes in one sample from one lot of Raw Frozen Primal Patties for Dogs Beef Formula. Primal Dog Food uses fresh and raw ingredients with minimal processing for its recipes. While not required from a regulatory standpoint, we have enhanced our nutritional testing to include a Test & Hold program. Sources: FDA. Cancel any time. 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. Warning letters often are not issued until a company has been given months to years to correct problems. We have received no complaints or reports of illness to pets or humans from this lot. To make the most of the. No spam ever. 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. Withdrawals, & Young children, elderly people, pregnant women, and those with weakened immune systems are particularly vulnerable to Listeria monocytogenes infections and symptoms can be more severe. 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 ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. fda.gov Manage Settings Pathogens in pet food can make people as well as pets sick. The main ingredient of this formula is cage-free, fresh, and organic beef. United States. This particular distribution center stores and ships products to 404 different Family Dollar stores, so pet food that was sent to any of those stores since January 1, 2022, has been recalled. To build on these controls and further ensure the safety of our foods, we started implementing the use of HPP across all our frozen raw red meat formulas, like we already had in place on poultry formulas. Do you use the whole apple including core and seeds in your formulas? 20002023 The Animal Rescue Site and GreaterGood. Additionally, although the revised study report references Selective Enrichment, you used non-selective (b)(4) and a non-selective (b)(4). The recipes use selected foods, making the ingredient list high-quality and transparent. 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. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. What is the pH of your foods? Why it was recalled: Natural Balance recalled its L.I.D. Pet parents are also encouraged to follow all safe handling instructions on Primal packaging and wash their hands and all preparation surfaces after handling any raw product. . However, their prerequisite program was either insufficient or they failed to implement it adequately to manage the hazard. Just for Fun. Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have destroyed the food in accordance with SOP-722. Specifically, your reliance on your testing prerequisite program failed to reduce the probability that a nutrient deficiency or toxicity will occur in your pet food in the absence of a preventive control. If you've recently purchased your pup food from Primal Pet Foods, you'll want to double-check the details on the packaging. The lot number and best by date can be found on the lower third of the back of the Raw Frozen Primal Patties package. (You could get sick, too, if you dont wash your hands after handling it.). 342(a)(4)] and 21 CFR 507.1(a)(1)(ii). Freeze-dried raw, minimally processed dog food delivers the highest digestibility for maximum nutrient absorption to help support healthy weight, reduced stool volume, healthy skin and coat, oral health, and clear eyes. What's Being Recalled? (2) NUTRIENT TESTING. Start your day with heartwarming and hilarious animal stories that will make you fall in love. Some of the enhancements we have made over the past year include onboarding a dedicated PhD Companion Animal Nutritionist, upgrading our formulation software, and increasing the frequency of our finished product nutritional testing to monthly versus quarterly. Primal Pet Foods is committed to the quality and safety of its products. We may earn a commission if you purchase from our links. This letter notifies you of our concerns and provides you an opportunity to address them. This product should be kept frozen until a pet parent is ready to use it. The firm does not perform cleaning between batches of the same recipe and only performs a (redacted) when transitioning between different recipes. On behalf of our Primal team, I wanted to make you aware of a voluntary recall we are conducting on 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 monocytogenes. 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 Your revised study indicates (b)(4) detection was performed using the (b)(4) for Salmonella, following (b)(4) methodology. The inspection followed a recall of the company's products in July 2022 predicated by the agency's detection of Listeria monocytogenes in Raw Frozen Primal Patties . Your response also provided a protocol for a validation study to be conducted by (b)(4) for using (b)(4) as a preventive control for Listeria monocytogenes in freeze-dried products. 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. Pet parents are also encouraged to follow all safe handling instructions on our packaging. Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. Anyone exhibiting symptoms after handling this product should contact their healthcare provider. Like some other dog food formulas, Primal Pet Foods says that their formulas closely imitate the diet of dogs in the wild. In addition, you are updating your good manufacturing practices and will provide training on your new procedures, increase your environmental monitoring swab sites, and will provide training on your CAPA procedures. 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. Limited Ingredient Diets Green Pea & Chicken dry cat food because of potential salmonella contamination. An animal food firm in California is on notice from the FDA for serious violations of the FDAs Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation, including Listeria found in the finished product. If you were affected by this recall, an excellent alternative is The Farmer's Dog. Office of Human and Animal Food Operations- West Division 5, CC: Matthew Koss, Founder/Chief Product Officer via email @ Matt@primalpetgroup.com. 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 revealed the presence of Listeria monocytogenes. Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. The voluntary recall was issued when the US Food and Drink Administration did a routine sampling and detected a positive test for listeria. Violations resulted in the issuance of an FDA Form 483. 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. Limited Ingredient Diets Green Pea & Chicken dry cat food, Meow Mix Original Choice dry cat food were recalled, Midwestern Pet Foods recalled all dog and cat food, recalled 4-pound bags of Billy+Margot Wild Kangaroo And Superfoods, Sunshine Mills recalled some dog food products, recalled its Ultra Premium Chicken & Liver Pat cat food, Texas Tripe recalled 23 different raw pet food products, issued a recall on its Kitten Grind raw pet food, Do Not Sell or Share My Personal Information. 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. Thus, their manufacturing facility is not a retail food establishment. These positive results demonstrate the controls they have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that . The recall comes after two reported kitten deaths one of the deaths was confirmed to be a result of salmonella exposure. No other Primal lot codes or products are impacted by this voluntary recall. But how would you even know if your go-to foods been recalled? 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. All of the ingredients are carefully sourced and free of added hormones and steroids. 4. The AAFCO Food Nutrient Profiles for thiamine in feline diets identifies a minimum level of 5.6 mg/kg. If you have any questions, please view our recall FAQs or 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. 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. Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. Review: Based on customer feedback, this Primal Beef Topper has an average rating of 4.8 out of 5 stars. Routine sampling by the U.S. Food and Drug Administration found the bacteria Listeria monocytogenes, which can cause listeriosis (listeria), in one sample from one lot of this product. 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. The company is recalling 66 cases of the patties that were distributed to Maryland, Georgia, Texas, and British Columbia in April 2022. 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 U.S. Food and Drug Administration (FDA) conducted a routine inspection of our Fairfield, California, facility following our voluntary recall of Raw Frozen Beef Patties last summer. Subscribe to The Dog Food Advisors emergency recall warning system. In its recall notice, the company said the 66 cases396 bags of foodwere distributed . 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. 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. Your response stated you are updating your food safety plan to add a sanitation preventive control and will review and update all associated procedures, checklists, and pre-operational instructions. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. Help us keep pet food companies in check. Beef is a premium source of protein and is balanced with sweet potatoes, cherry tomatoes, kale, and ginger: all of which are superfoods rich in vitamins and antioxidants. The Primal Pet Foods recall: Which products are affected A single lot of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound) is being recalled. This voluntary recall is a result of routine sampling by the FDA, which revealed one positive result for Listeria monocytogenes in one lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula. Credit: 24K-Production / Getty. The Minnesota Department of Agriculture flagged the health risk after a routine state surveillance sample. 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. 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 firms Director of Quality informed FDAs Investigators that the majority of their product (approximately (redacted) percent) is shipped directly to consumers from third-party warehouses rather than from their facility. You can also report your complaint by visiting the FDA's " Report a Pet Food Complaint. 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. Limited accessibility due to high price tag, Grain and legume-free formula fit for sensitive stomachs, Contains superfoods blended with rich protein from beef, Free of added hormones, fillers, and preservatives, Chew-size fit for both small and large breed dogs of all ages, Primal Frozen Nuggets Turkey & Sardine Formula, Primal Frozen Patties Turkey & Sardine Formula, Primal Freeze-Dried Nuggets Chicken Formula, Primal Freeze-Dried Nuggets Rabbit Formula, Primal Freeze-Dried Nuggets Turkey & Sardine Formula, Primal Freeze-Dried Nuggets Venison Formula, July 2022: A voluntary recall by Primal dog food a single lot of Primal Raw Frozen Primal Patties for Dogs Beef Formula for. 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