"August 22, 2024, an FDA Investigator purchased samples of your Answers raw pet food from a retailer in Nevada in response to consumer complaints. Sample analysis revealed that all four sampled lots contained Salmonella and/or Listeria monocytogenes, as described below. Therefore, your Answers Pet Food Raw Beef Detailed Formula, lot May 06 2026, Answers Pet Food Raw Beef Straight Formula, lot Jan 31 2026, and your Answers Pet Food Straight Chicken Formula, lots Jan 02 2026 and Mar 11 2026, are adulterate"First, the fact that the pathogens were present, meant that identified preventive controls were not adequate.
"Your food safety plan identifies process, sanitation, and supply chain preventive controls as part of your “(b)(4) technology” to control pathogens. Yet, your preventive controls are not adequate as shown by the following samples of four products collected at retail and analyzed by FDA that contain Salmonella, L. monocytogenes, or both:"The company identified sanitation preventive controls, but were not sufficient because Salmonella was present in the environment.
The company identified supply chain preventive controls, but did not have evidence for that control."Your hazard analysis identified Sanitation Standard Operating Procedures (SSOPs) and current good manufacturing practices (CGMPs) as a preventive control for biological hazards (which include pathogens) in your raw pet food at steps (b)(4) of your whey mixture containing lactic acid bacteria (LAB). Inspectional findings that indicate your sanitation preventive control is inadequate include:i. FDA Investigators collected environmental samples on July 23, 2024, under sample 1263703, that revealed the presence of L. monocytogenes on seven surfaces in your facility, including Zone (b)(4) food-contact surfaces."
"you were unable to provide COAs for turkey and pork ingredients used to manufacture your raw pet food between July 22 and July 24, 2024" "You did not provide documentation of annual onsite audits for your suppliers during the inspection, and you do not have a written justification for accepting LOGs and/or COAs from ingredient suppliers in lieu of an annual onsite audit at your suppliers."GMP issues were also noted in this report.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lystn-llc-dba-answers-pet-food-694680-06182025
Lystn LLC dba Answers Pet Food
