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FDA issues warning letter to Answers Pet Food after finding Salmonella, Listeria

FDA issues warning letter to Answers Pet Food after finding Salmonella, Listeria

FDA issues warning letter to Answers Pet Food after finding Salmonella, Listeria

On June 18, 2025, the U.S. Food and Drug Administration issued a warning letter to Lystn LLC, doing business as Answers Pet Food, following a July-October 2024 inspection of the company’s Elizabethville, Pennsylvania, U.S. facility that uncovered violations of current good manufacturing practices and preventive controls requirements.

The FDA initiated the inspection after receiving three consumer complaints of illness in dogs that ate the products. The agency found Salmonella and Listeria monocytogenes contamination in four retail-sampled product lots, including Raw Beef Detailed Formula, Raw Beef Straight Formula, and two lots of Straight Chicken Formula. Environmental sampling during the inspection revealed L. monocytogenes on seven facility surfaces, including food-contact surfaces, with whole genome sequencing confirming a genetic match between environmental samples and finished product contamination.

FDA issued a public advisory regarding the contaminated products on September 23, 2024. It recommended that Answers Pet Food recall these products. 

The agency cited three primary violations: failure to implement adequate preventive controls to minimize biological hazards, insufficient supplier verification activities including lack of required annual onsite audits for suppliers of ingredients posing serious health risks, and inadequate precautions during plant operations that contributed to contamination risks.

Answers Pet Food submitted written responses to the FDA’s Form 483 observations on October 18 and November 12, 2024. The company emphasized its proprietary technology for pathogen control and updated several procedures, including environmental monitoring protocols and plant cleaning procedures. However, the FDA noted it could not adequately assess these changes due to lack of supporting documentation showing consistent implementation of the new procedures.

With this latest warning letter, Answers Pet Food was required to provide written notification to the FDA within 15 working days of receiving the warning letter, detailing specific corrective actions taken to address violations. The response was to include explanations of steps to prevent recurrence and copies of related documentation. The FDA warned that failure to adequately address these matters may result in legal action, including seizure and injunction.