A Letter From Matt Koss & Lindsay Meyers
March 24, 2023
Our Valued Pet Retail Partners,
On behalf of our Primal Pet Foods team, we want to provide you with additional details about our recent response to a Warning Letter issued by the U.S. Food and Drug Administration (FDA). 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. We worked closely with the FDA inspectors to review our existing food safety plan and identify enhancements to both policies and processes.
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. We responded in a timely manner and provided supporting documentation to demonstrate how our team is consistently implementing critical processes. We expect the FDA to be fully satisfied with our response and the steps we are taking to ensure we continue to make raw food even safer for our consumers and their pets.
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 FDA’s Warning Letter and the steps we have taken to continuously strengthen our food safety plan.
Below, we’ve outlined the four aspects that we addressed in our response to the FDA:
(1) Preventive Controls. The FDA believed the hazard preventative controls we had in place at the time of the voluntary recall last July were not adequate. Prior to the inspection, our food safety program included the following controls – the use of high-quality, edible grade raw materials, inbound raw material testing, a supplier approval program, and a finished product Test & Hold protocol. 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.
(2) Nutrient Testing. The FDA commented on the nutritional testing prerequisite program we had in place at the time of inspection. This program is in place to ensure that our Formulas contain safe levels of required nutrients, such as Vitamin D and Thiamine as set forth by AAFCO. 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. While the nutrient tests that the FDA noted were technically out of compliance, the slight variance was not a health concern for pets. We’ve also increased the frequency of our nutrient testing process to ensure this doesn’t happen again.
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. 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. While not required from a regulatory standpoint, we have enhanced our nutritional testing to include a Test & Hold program. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. In addition to the enhanced finished product nutritional testing, we have also increased the frequency of nutrient testing on raw materials to continuously validate that our natural, non-synthetic ingredients are delivering adequate and safe levels of required nutrients.
(3) Validation of Probiotics. During the FDA inspection, we provided a high-level summary from the third-party validation of the effectiveness of probiotics for safety. 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. In our response to the FDA, we shared the detailed studies that validate probiotics as a preventive control for pathogens such as Salmonella and Listeria. 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.
(4) Sanitation Preventive Control. While we did have some microbial test results return positive for harmful pathogens, those products were not released for sale – the Warning Letter demonstrates that our strict Test & Hold Program is effective. Additionally, we added more sanitation preventive controls to our food safety plan and increased environmental monitoring swab sites in our facility. In our response to the FDA, we provided documentation that shows how we’ve implemented these changes and are properly training our manufacturing team members on our detailed sanitation processes.
If you have any follow up questions about our food safety plan, the content of the FDA’s letter and/or our response, please contact us 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 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.
Founder and Chief Product Officer
Lindsay Meyers, CVT
Vice President, Quality Assurance, Nutrition & Regulatory Compliance