FDA WARNING_LETTER - Mid America Pet Food LLC - December 18, 2023

The FDA issued a Warning Letter to a pet food manufacturing facility following inspections from November 2, 2023, to December 18, 2023, and January 23, 2024, to February 9, 2024. These inspections were prompted by voluntary Class I recalls of dog and cat food due to potential Salmonella contamination, and an investigation into a multi-state human Salmonella Kiambu outbreak linked to the facility's dog food, which hospitalized one person and affected six children under one year old.

The FDA found significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), rendering products adulterated. Violations included failure to adequately implement sanitation controls (e.g., improper sanitizer use, incomplete sanitation records, visible debris after cleaning) and process controls (e.g., inadequate documentation and application of chicken fat treatment). Environmental samples revealed three resident Salmonella strains (Rissen, Minnesota, Mbandaka) in the facility, with positive swabs found in both pre- and post-process areas.

Additionally, the facility failed to take appropriate corrective actions when preventive controls were ineffective. This included not conducting root cause analyses for Salmonella-positive finished product samples and not performing required "vector swabs" or assessing food safety impact after environmental positives. The company's responses regarding corrective actions were deemed insufficient or incomplete, with some issues persisting