The U.S. Food and Drug Administration (FDA) conducted an inspection of a raw pet food manufacturing facility operated by Answers Pet Food at 38 South Franklin Street, Elizabethville, Pennsylvania, from July 18 through October 4, 2024. The inspection revealed significant violations of federal manufacturing and safety requirements for animal food products.
Contaminated Products Identified
FDA investigators purchased samples of Answers raw pet food from a Nevada retailer in August 2024 following consumer complaints. Laboratory analysis revealed that all four sampled product lots contained dangerous bacteria. The contaminated products included Answers Pet Food Raw Beef Detailed Formula, Answers Pet Food Raw Beef Straight Formula, and two lots of Answers Pet Food Straight Chicken Formula. These products tested positive for Salmonella Newport, Salmonella Kentucky, Salmonella Typhimurium, and Listeria monocytogenes bacteria.
The FDA issued a public advisory regarding these contaminated products on September 23, 2024, warning consumers about the potential health risks associated with these bacterial contaminants.
Facility Contamination Discovered
Environmental testing conducted during the inspection revealed extensive contamination within the manufacturing facility itself. FDA investigators collected environmental samples on July 23, 2024, which showed the presence of Listeria monocytogenes on seven different surfaces throughout the facility, including food-contact surfaces in critical production areas.
Whole genome sequencing analysis conducted by the FDA determined that bacterial samples from two environmental surfaces genetically matched the Listeria monocytogenes found in one of the finished pet food products, demonstrating a direct link between facility contamination and product contamination.
Regulatory Violations Documented
The inspection identified multiple violations of Current Good Manufacturing Practice requirements and Hazard Analysis and Risk-Based Preventive Controls regulations. The facility failed to implement adequate preventive controls to minimize or prevent hazards, despite having a food safety plan that identified biological hazards including Salmonella and Listeria as requiring preventive controls.
The company’s sanitation procedures were deemed inadequate, as evidenced by the widespread presence of dangerous bacteria on facility surfaces and in finished products. Investigators observed improper employee hygiene practices, including workers handling packaging materials and trash before returning to food production without changing gloves or washing hands.
Additional violations included inadequate water usage during production, where investigators observed water splashing from non-food contact surfaces onto in-process pet food products during cleaning operations.
Supply Chain Control Deficiencies
The facility also failed to meet supply chain verification requirements. While the company’s food safety plan identified supply-chain controls for pathogenic bacteria, the facility could not provide certificates of analysis for turkey and pork ingredients used in production. The company relied on general letters of guarantee from suppliers rather than conducting required annual onsite audits for hazards that could cause serious adverse health consequences.
Company Response and Follow-up
The company provided written responses to FDA observations on October 18 and November 12, 2024. While the company outlined various corrective measures including increased cleaning procedures and additional environmental testing, the FDA determined that insufficient supporting documentation was provided to assess the adequacy of these corrections.
The FDA has indicated that verification of corrective actions will occur during future inspections. The agency has requested documentation of specific corrective steps within fifteen working days and warned that failure to adequately address violations may result in legal action, including seizure and injunction proceedings.
