On June 18, 2025, Answers Pet Food was issued a Warning Letter from FDA.
The Warning Letter was issued after an inspection (follow up to Answers recall in September 2024).
Quotes from the Warning Letter:
“You did not implement sanitation controls to provide assurances that your facility is maintained in a sanitary condition adequate to significantly minimize or prevent the hazard of environmental pathogens, as required by 21 CFR 507.34(a)(1) and (c)(2).”
“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.
• Subsample 15, Zone (b)(4), collected on the (b)(4) above the (b)(4) grinder hopper.
• Subsample 20, Zone (b)(4), collected on the (b)(4) of the mixer.
• Subsample 30, Zone (b)(4), collected on the (b)(4) next to the (b)(4).
• Subsample 34, Zone (b)(4), collected on the (b)(4) next to the (b)(4) adjacent to the (b)(4) table.
• Subsample 36, Zone (b)(4), collected on an apparent (b)(4) for the (b)(4) directly above the (b)(4) conveyer from the (b)(4) grinder to the (b)(4) grinder.
• Subsample 41, Zone (b)(4), collected on a (b)(4) of a (b)(4) in the food manufacturing area.
• Subsample 44, Zone (b)(4), collected on the (b)(4) leading to the (b)(4).”
“In your response dated October 18, 2024, you said you discussed FDA’s observations with your staff, you are increasing cleaning and sanitizing prior to production, and you are implementing additional swabbing and environmental testing. However, we are unable to assess these changes because you did not provide supporting evidence that the new procedures provided in the exhibits to your response have been consistently and adequately implemented. We will verify and evaluate your corrections during the next inspection.”
“Your procedure ‘Program for Supply Chain Control,’ dated July 24, 2024, indicates that when applicable you will collect letters of guarantee (LOGs) and/or certificates of analysis (COAs) from your suppliers. You did not determine and conduct appropriate supplier verification activities and satisfy all documentation requirements, as required by 21 CFR 507.115(a)(2).”
“…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.”
To read the full FDA Warning Letter, Click Here.
Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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