FDA EIR - Unknown Company - April 01, 2021

An FDA compliance follow-up inspection of a dry kibble pet food manufacturer, conducted between August and October 2021, focused on environmental hygiene within the facility. The inspection, overseen by the FDA Office of Regulatory Affairs, involved collecting environmental swabs for pathogenic bacteria. Several samples yielded positive results for Salmonella, specifically identifying Salmonella ssp. I, Group T and Salmonella enterica ssp. I 42:z4,z23:- Gr.T. One particular sample initially led to an "Official Action Indicated" (OAI), signifying a significant compliance concern requiring regulatory attention under food safety regulations for animal food. Further laboratory testing on related samples showed mixed conclusions, with some indicating "Adverse Findings" but no further "Regulatory Action Indicated," and others showing "No Action Indicated" for Salmonella. For the sample that initially triggered the OAI, the disposition was later documented as "Legal Or Other Action Closed," suggesting the initial compliance issue was addressed. Additionally, a separate surveillance sample of "Bites & Bones" dry dog kibble was tested for aflatoxins and found to be in compliance with "No Action Indicated." The primary regulatory concern revolved around environmental Salmonella contamination, highlighting the importance of pathogen control in pet food manufacturing facilities under FDA's oversight.