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During FDAs 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. If you bought the recalled product, you should stop feeding it to your dog and throw it away. Pathogens in pet food can make people as well as pets sick. You 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, as provided in 21 CFR 507.42(b)(1)(ii), 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 by 507.42(b)(2). Details for the recall are listed below. To learn more about our product safety assurance and test and hold protocols, please click here. 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. The company uses a test and hold protocol to ensure that all products test negative for harmful bacteria before being released for sale. 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. 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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Primal Dog Food uses fresh and raw ingredients with minimal processing for its recipes. The only products affected have the lot code V 07. However, we failed to provide the detailed scientific studies that demonstrate the effectiveness of probiotics in our freeze-dried and frozen products using our equipment parameters. fda.gov The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. They market their formulas as being 100% "human-grade" raw foods and treats. If you have purchased the product you should immediately discard the product and stop feeding it to your dogs. 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. If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. All recipes use organic vegetables, fruits, unrefined vitamins, and minerals. Based on conversations our team members have had with many of you over the last week, we are providing additional details about the content of the FDAs Warning Letter and the steps we have taken to continuously strengthen our food safety plan. We have temperature tracking devices on all shipments to ensure storage requirements are met while being transported. Your revised study indicates (b)(4) detection was performed using the (b)(4) for Salmonella, following (b)(4) methodology. If you buy something from a link on our site, we may earn a commission. Consumers with questions are invited to contact the company by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. Elevated levels of aflatoxin. Specifically, your firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. 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). If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. Our mission is to provide pet parents just like you with the most up-to-date expert information and resources you need to make better, more informed decisions that support the health and happiness of your companion animals. Overall, Primal Dog Food is a good choice of nutritious and healthy food for dogs. Why it was recalled: Freshpet recalled 4.5-pound bags of the Fresh From The Kitchen Home Cooked Chicken Recipe for possible salmonella contamination. According to a company release, 1 this recall is a result of routine sampling by the U.S. Food and Drug Administration, which discovered a positive result for Listeria monocytogenes in 1 sample from 1 lot of Raw Frozen Primal Patties for Dogs Beef Formula. Probiotics present in treated freeze-dried raw beef samples contain high levels of background flora which can suppress the growth of Salmonella and decrease the sensitivity of detecting Salmonella. Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt; 03/10/2023: Purina: Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food Overall, Primal Dog Food is a good choice of nutritious and, 2022 Veterinarian.org, LLC. The lots were produced with bone that was not ground to the specifications the company has set. An example of data being processed may be a unique identifier stored in a cookie. Thank you. People can become sick by handling. FDA does not endorse either the product or the company. Pet owners say this is quality organic produce that their dogs love and get excited for. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide adequate supporting documentation to demonstrate the promised corrections have been completed and consistently implemented. 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. We received your written response dated November 1, 2022. Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. We have received no complaints or reports of illness to pets or humans from this lot. You also stated that if any product tests positive on a particular shift, all product manufactured on that shift will be sent for rework. As a result, the company has recalled a single lot of 6-pound Raw Frozen Primal Patties for Dogs. On September 2, 2020, Sunshine Mills announced a recall of certain pet food products after a retail product sample was found by the Louisiana Department of Agriculture & Forestry to contain. Primal Pet Foods. The product has lot number #W10068709 and a best by date of May 22, 2023. 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. The Guaranteed Analysis for Primal Beef Raw Frozen Formula is: Crude Protein (min) 14% Crude Fat (min) 14% Crude Fiber (max) 1% Moisture (max) 67% Ash (max): 2.5% Primal Dog Food Recall History There is no history of any Primal dog food recalls within the past two years, according to the FDA. Explore REcipes. Why it was recalled: Natural Balance recalled its Ultra Premium Chicken & Liver Pat cat food after receiving reports of adverse reactions. Simply crumble the freeze-dried nuggets and rehydrate with water, Bone Broth, or Raw Goat Milk. Symptoms of aflatoxin poisoning include: According to the companys announcement, this recall was issued out of an abundance of caution, and only applies to those products from that specific facility in Chickasha that have expiration dates on or before July 9, 2022. Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, abdominal pain, diarrhea, confusion, loss of balance and convulsions. 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. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. Their production process involves adding a quantity of (redacted) ppm PAA into their pet food. 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. 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. Come along for the ride! 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. Its rare for dogs to get sick from being exposed to Listeria monocytogenes, but it can happen. More info A food recall is issued when a product is unsafe for people to eat. Plus, compared to traditional kibble, it is healthier and more enticing. More Recalls, Market Alameda, CA 94502. The ingredients are carefully selected to make balanced meal recipes that improve dogs . 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. If pet parents have any questions, they can 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. . Office of Human and Animal Food Operations- West Division 5, CC: Matthew Koss, Founder/Chief Product Officer via email @ Matt@primalpetgroup.com. 4. 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. This Pregnant Pittie Foster Story Is The Happiest Thing Ever. Your response stated your firm will no longer utilize supplier approval or outbound microbiological testing as preventive controls for pathogens. 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. Why it was recalled:Texas Tripe recalled 23 different raw pet food products across 35 different lots after samples tested by the Office of the Texas State Chemist found salmonella and listeria in over half of those samples. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. The protein sources are organic and free of antibiotics, steroids, and hormones. All 2020 dog food recalls are listed in the table below. Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product. Business owners have 15 days to respond to FDA warning letters. 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. 2, or contact your nearest FDA consumer complaint coordinator with any questions. 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. While the FDA was satisfied with our voluntary recall process and terminated the recall in late January 2023, they issued a Warning Letter to request additional information about our food safety plan. Dogs can have mild symptoms such as diarrhea and vomiting. When it was recalled: July 6, 2022 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. Before sharing sensitive information, make sure you're on a federal government site. The lot number and best by date will be listed on the lower third of the bag. Since the original recall announcement on Feb 8, 2023, Purina expanded the recall on March 10, 2023 to two additional product lots. No other lot codes or Primal products are impacted by this announcement. You can find the lot number and best by date on the back of the food packaging. Why it was recalled: One-pound packages of Beef HVM from Top Quality Dog Food were recalled for potential exposure to salmonella and listeria. 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. Based on recent conversations we have had with many of our retail partners, we areproviding additional detailsabout the content of the FDAs Warning Letter and the steps we have taken to continuously strengthen our food safety plan. Please follow this link or see below for a letter from Matt Koss and Lindsay Meyers, CVT. According to the announcement from Top Quality Dog Food, anyone who received a package with that lot number should have been contacted already. At present, Primal Dog Food is a widely accepted pet food brand that has improved the health of innumerable dogs all over the world. A large breed dog (up to 75 pounds) should eat up to 2 cups of dry food per day. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all food safety standards. 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. 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. Some pups may not show any symptoms if they develop listeria. You did not validate that the process preventive control you identified and implemented in accordance with 21 CFR 507.34 is adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facilitys food safety system, as required by 21CFR 507.47(a). 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. 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. 331(a)]. In addition, your firm failed to reduce the likelihood the problem will recur as evidenced by your testing showing four lots of finished product found positive for pathogens after implementation of your corrective actions in response to the recall. Third of the fresh from the Kitchen Home Cooked Chicken Recipe for possible contamination. 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