Primal Pet Foods responded to claims made by the United States Food and Drug Administration (FDA) in its warning letter sent in February. Agency representatives conducted an inspection at Primal Pet Foods’ manufacturing facility in Fairfield, California following their recall due to detection of Listeria monocytogenes in Raw Frozen Primal Patties for Dogs Beef Formula in July 2022.
Primal Pet Foods’ Response to FDA Warning Letter
In response to this section of the warning letter from the FDA, Primal Pet Foods provided 49 products manufactured between August 2021-2022 that tested positive for Listeria monocytogenes or Salmonella spp. during an inspection conducted between August 2021-2022 by Primal Pet Foods that tested positive during their inspection process.
“While some microbial test results came back positive for harmful pathogens, those products were never released for sale and our test and hold Program was effective,” Jilliann Smith, Vice President of Communications for Primal Pet Group LLC told Petfood Industry. Furthermore, additional sanitation preventive controls were added to our food safety plan as well as environmental monitoring swab sites in our facility and increased environmental monitoring swab sites within our facility. To demonstrate these changes to FDA we provided documentation proving them, as well as training our manufacturing team members on our detailed sanitation processes.”
Primal responded to this section of the warning letter by declaring they will no longer use supplier approval and outbound microbiological testing as preventative controls for pathogens.
“FDA believed our hazard preventative controls at the time of our voluntary recall last July were inadequate,” Smith stated. Prior to their inspection, our food safety program featured high-quality edible grade raw materials; inbound raw material testing; supplier approval programs and finished product test and hold protocols as controls. To enhance these measures and further ensure food safety for our consumers, HPP technology was introduced across our frozen raw red meat formulas, just as had already been implemented across poultry formulas.
Primal Pet Foods Warning Letter
The Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation is designed to ensure animal food is safe for consumption, helping prevent foodborne illness among animals which could then spread onto humans who consume animal products.
CGMP regulations mandate that animal food manufacturers adhere to specific procedures when producing, storing and distributing animal food products. This includes keeping facilities clean and sanitary at all times; using equipment in good working order that has been regularly serviced and cleaned; as well as developing procedures designed to prevent contamination during production and storage processes.
Hazard Analysis and Risk-Based Preventive Controls (HARPC) component of the regulation requires animal food manufacturers to identify any potential hazards associated with their products, and implement controls that prevent or minimize those dangers. They must create a written food safety plan outlining both potential hazards as well as steps taken to manage them.
Under the HARPC Rule, manufacturers must conduct periodic reviews of their food safety plans to ensure they remain effective and current.
Overall, CGMP and HARPC regulations play a vital role in ensuring animal food manufacturers produce and distribute it in an ethical and sanitary manner. Adherence to these standards helps reduce foodborne illness in both animals and humans alike.