Why it was recalled: Natural Balance recalled its Ultra Premium Chicken & Liver Pat cat food after receiving reports of adverse reactions. Matt Koss Founder and Chief Product Officer, Cats, 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 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. To make the most of the. This. The Dog Food Advisor first became aware of the warning on March 21, 2023. Business owners have 15 days to respond to FDA warning letters. They also conduct a test and hold procedure for all their products to ensure that they are free of harmful bacteria. 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. Both these diseases can make you or your dog really sick. Since these products were exposed to rats, they could be contaminated with salmonella bacteria, which means your pet can get really sick if he eats that food. If you were affected by this recall, an excellent alternative is The Farmer's Dog. In late April 2022, Primal Pet Foods distributed 66 cases (396 units) of this single lot . 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. 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. These positive results demonstrate the controls they have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. Small dogs (up to 10 pounds) should eat cup to cup of dry food per day. 331(uu)]. Tips, Cats, If your pet has been eating this food and shows signs of discomfort or illness please contact your veterinarian immediately. If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. Primal Pet Foods. The lot number on the product is #W10068709, with a best-buy date of 05/22/23. March 29, 2023 The Food and Drug Administration (FDA) posted a Warning Letter to Primal Pet Foods, Inc. of Fairfield, California. Under section 409(a) of the FD&C Act [21 U.S.C. Primal dog food is not listed on the FDA's pet food recall website, and has not been involved in any recent recalls. This Primal recall is just one of over 39 recalls that have occurred in the past year. According to the companys announcement, this food was recalled out of an abundance of caution.. Dogs, The main ingredient of this formula is cage-free, fresh, and organic beef. What's Being Recalled? 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. 1 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. Specifically, their firm adds (redacted) as a preventive control for pathogens for their freeze-dried products. The FDAs inspection revealed that the firm was not in compliance with FDA regulations, specifically the FDAs Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulation. They market their formulas as being 100% "human-grade" raw foods and treats. The lots were produced with bone that was not ground to the specifications the company has set. We are unable to further evaluate this corrective action until we can review the final study report. HAF Division West 5 These violations resulted in the issuance of an FDA Form 483. 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. Withdrawals, & As of this publish date, theres only one active pet food recall from 2019. December 2017: A voluntary recall of dog food by Primal, as the bone size of the ground bone in the formula was not ideal and could disbalance the formulation. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. The firm does not perform cleaning between batches of the same recipe and only performs a (redacted) when transitioning between different recipes. 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. 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. 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. Pet owners say this is quality organic produce that their dogs love and get excited for. Help us keep pet food companies in check. An animal food firm in Washington is on notice from the FDA for not being in compliance with FDA regulations due to adulterated animal food, including finished products with Salmonella. Why it was recalled:Midwestern Pet Foods recalled all dog and cat food made with corn products that were produced at an operations facility in Chickasha, Oklahoma, due to excessive aflatoxin levels. 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. . Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product. 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. MATT KOSSFounder and Chief Product Officer, LINDSAY MEYERS, CVTVice President, Quality Assurance, Nutrition & Regulatory Compliance, Voluntary Recall Announcement July 6, 2022. Primal Pet Foods is recalling a single lot of its frozen beef patty dog food after a sample tested positive for listeria. (4) SANITATION PREVENTIVE CONTROL. This was issued after routine FDA sampling found listeria in food from one specific lot. Well send you our daily roundup of all our favorite stories from across the site, from travel to food to shopping to entertainment. 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). Cancel any time. 2. All recipes use organic vegetables, fruits, unrefined vitamins, and minerals. The specific products recalled include the 15-ounce container and the 5-pound tub, both of which have expiration dates of November 20, 2022. 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). 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 Salmonella spp. The food was recalled after the Minnesota Department of Agriculture found salmonella in a 5-pound bag of Sprout Sporting Dog Food during routine testing. FDA inspected the firms facility in June 2021, and subsequently sent them a letter dated Aug. 27, 2021, documenting our concerns with their use of PAA as a pathogen mitigation step to reduce E. coli O157:H7 and Salmonella spp. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes . This product should be kept frozen until a pet parent is ready to use it. In our response to the FDA, we provided documentation that shows how weve implemented these changes and are properly training our manufacturing team members on our detailed sanitation processes. 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. (According to the FDA, listeria infections arent too common in pets but can still happen.). Primal is one of the few raw diet brands that make safe. 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. Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. At the close of the inspection, you were issued a Form FDA-483, Inspectional Observations. The inspections were conducted in response to a recall of Primal's Raw Frozen Primal Patties for Dogs Beef Formula on July 6, 2022. Return the recalled food to the store or retailer you purchased it from for a refund. 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. Primal dog food uses bones, meat, and organ meat from these protein sources for its recipes. 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. 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. 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. Affected products are 2-pound rolls from lot GA1102. If you have this product in your possession, discontinue use immediately, and return the food to the purchaser for full credit. There are two major types of pet food recalls: voluntary recalls, which are issued by the company, and ordered recalls, which come directly from the FDA. 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. The protein sources are organic and free of antibiotics, steroids, and hormones. 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. 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. For example, the lab report numbered 21-029-9570 with a sample received date of January 14, 2021, for the product Feline Chicken & Salmon Formula Freeze Dried (lot W10022504), reported thiamine levels based on dry weight as 3.96 mg/kg. 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. 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