On June 18, 2025, Solutions Pet Meals was issued a Warning Letter from FDA.
The Warning Letter was issued after an inspection (observe as much as Solutions recall in September 2024).
Quotes from the Warning Letter:
“You didn’t implement sanitation controls to supply assurances that your facility is maintained in a sanitary situation satisfactory to considerably decrease or stop the hazard of environmental pathogens, as required by 21 CFR 507.34(a)(1) and (c)(2).”
“Inspectional findings that point out your sanitation preventive management is insufficient embody:
“i. FDA Investigators collected environmental samples on July 23, 2024, below pattern 1263703, that exposed the presence of L. monocytogenes on seven surfaces in your facility, together with 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) subsequent to the (b)(4).• Subsample 34, Zone (b)(4), collected on the (b)(4) subsequent to the (b)(4) adjoining to the (b)(4) desk.• Subsample 36, Zone (b)(4), collected on an obvious (b)(4) for the (b)(4) straight 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) within the meals manufacturing space.• Subsample 44, Zone (b)(4), collected on the (b)(4) resulting in the (b)(4).”
“In your response dated October 18, 2024, you mentioned you mentioned FDA’s observations together with your employees, you might be rising cleansing and sanitizing previous to manufacturing, and you might be implementing extra swabbing and environmental testing. Nevertheless, we’re unable to evaluate these adjustments since you didn’t present supporting proof that the brand new procedures offered within the reveals to your response have been persistently and adequately applied. We’ll confirm and consider your corrections in the course of the subsequent inspection.”
“Your process ‘Program for Provide Chain Management,’ dated July 24, 2024, signifies that when relevant you’ll accumulate letters of assure (LOGs) and/or certificates of study (COAs) out of your suppliers. You didn’t decide and conduct acceptable provider verification actions and fulfill all documentation necessities, as required by 21 CFR 507.115(a)(2).”
“…you had been unable to supply COAs for turkey and pork components used to fabricate your uncooked pet meals between July 22 and July 24, 2024.”
To learn the complete FDA Warning Letter, Click on Right here.
Susan ThixtonPet Meals Security AdvocateAuthor Purchaser Beware, Co-Creator Dinner PAWsibleTruthaboutPetFood.comAssociation for Fact in Pet Meals
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