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. Owned and operated by CharityUSA.com, LLC. If a dog has consumed the recalled product, pet parents are encouraged to consult their veterinarian. 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. No spam ever. While we provide information resources and canine education, the content here is not a substitute for veterinary guidance. Sportmix. Your pets deserve better. This minimally processed blend of rich protein and healthy nutrients improves coat health, vision, and vitality in dogs. 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. 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. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. 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. The company is recalling 66 cases of the patties that were distributed to Maryland, Georgia, Texas, and British Columbia in April 2022. 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. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. Warning letters often are not issued until a company has been given months to years to correct problems. Improves vision, bone health, and vitality in dogs. If youre unable to return your recalled food, make sure you get rid of it so that other animals including wildlife cant eat it. 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. 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. You can find the lot number and best by date on the back of the food packaging. Dogs should eat according to their size. The company uses a test and hold protocol to ensure that all products test negative for harmful bacteria before being released for sale. 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. Perfect for picky eaters and dogs without grain sensitivities, this protein-rich formula combines traditional kibble with meaty bits that dogs crave. 2 See Section 301(a) of the FD&C Act [21 U.S.C. Program Division Director The recalled products are: Why it was recalled: Albrights Raw Dog Food recalled 67 cases of 2-pound rolls of its Chicken Recipe For Dogs because of potential salmonella contamination. 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. 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. We have reviewed your response and we discuss your corrective actions below, in relation to each of the noted violations. Listeria reportedly rarely causes illness in dogs, but if they are ill, it can cause symptoms like diarrhea and vomiting. According to the companys announcement, these issues are most likely associated with elevated levels of choline chloride in the food. Dogs can have mild symptoms such as diarrhea and vomiting. Anyone exhibiting symptoms after handling this product should contact their healthcare provider. Why it was recalled:Sunshine Mills recalled some dog food products because of the possibility that it contains excessive levels of aflatoxin. 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. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes . Fairfield, CA 94534-1790 Explore REcipes. If you feed your pup Raw Frozen Primal Patties for Dogs Beef Formula, you need to read this. These violations resulted in the issuance of an FDA Form 483. 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. Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. The two recalls were voluntary and didnt severely affect the health of any dogs. Alameda, CA 94502. Before sharing sensitive information, make sure you're on a federal government site. 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. 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. We have received no complaints or reports of illness to pets or humans from this lot. Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. BREAKING NEWS: Primal Pet Foods INC. has issued a voluntary recall of select lots of Primal Canine and Feline Freeze-Dried Poultry Formula. 348(a)(2)], an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated. 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. We are unable to further evaluate this corrective action until we can review the final study report. 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. TI1 3/APRIL/2020 TI2 3/APRIL/2020 TI3 3/APRIL . Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. The safety and quality of our products has always been my top priority. We worked closely with the FDA inspectors to review our existing food safety plan and identify enhancements to both policies and processes. FAIRFIELD, California, July 6, 2022 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 monocytogenes. An indication the controls you implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample (number 1146079) of your 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 described above. 331(a)]. Specifically, their firm manufactures raw frozen and raw freeze-dried pet food and treats for dogs and cats. We responded in a timely manner and provided supporting documentation to demonstrate how our team is consistently implementing critical processes. 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. Be sure to thoroughly wash your hands and clean your pups bowls and any other surfaces the food touched. Why does Primal include fish in its Formula diets? Your response stated you identified a new third party lab for all chemical testing and your testing method for vitamin D will include both vitamin D2 and D3; SOP-722 will be retired and product sampling, inspection and analysis SOP & guidelines will be updated; the addition of ingredients containing vitamin D and thiamine will be verified by review and sign-off; job cards for all products will be updated with current batch recipe amounts; training will be provided on the new supplement addition process; and your food safety plan and hazard analysis are being reviewed and updated with the assistance of a new food safety consultation company. If you've recently purchased your pup food from Primal Pet Foods, you'll want to double-check the details on the packaging. Affected products are 2-pound rolls from lot GA1102. 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. Made with fresh, crate-free Lamb raised without antibiotics, steroids or added hormones and USDA certified organic fruits and vegetables. Pathogens in pet food can make people as well as pets sick. 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. Both these diseases can make you or your dog really sick. If youre not sure whether your pets food is affected by the recall, please visit the Primal Pet Foods INC website for batch details. 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 . According to the companys announcement, this recall was issued as a precautionary measure.. This letter notifies you of our concerns and provides you an opportunity to address them. The company distributed sixty-six cases (396 units) of this single lot of Raw Frozen Primal Patties to Maryland, Georgia, Texas, and British Columbia, in late April 2022. 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. 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. A large breed dog (up to 75 pounds) should eat up to 2 cups of dry food per day. . Tips, Cats, Follow us on Instagram, Twitter, Pinterest, YouTube, TikTok, and Snapchat. 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