Salmonella outbreak tied to pet food spurs FDA warning letter over facility failures

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Mid America Pet Food LLC
Mount Pleasant, TX

The U.S. Food and Drug Administration has issued a warning letter to Mid America Pet Food LLC for significant violations at its Mount Pleasant, TX, facility that resulted in persistent Salmonella contamination of its pet food products. The letter, dated Nov. 22, 2024, followed two inspections conducted from Nov. 2 to Dec. 18, 2023, and from Jan. 23 to Feb. 9, 2024. These inspections revealed multiple regulatory violations under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (21 CFR Part 507).

The inspections were triggered by Mid America’s recalls in 2023, which included all dog and cat food products with best-by dates before Oct. 31, 2024. The recalls were linked to a multistate Salmonella Kiambu outbreak that sickened seven individuals, including six children under one year of age, and hospitalized one person.

Inspection findings

During the inspections, FDA investigators identified severe deficiencies, including the presence of multiple Salmonella strains in the facility’s environment, inadequately implemented preventive controls, and failures in sanitation and documentation.

1. Environmental contamination
   Investigators collected environmental samples during both inspections, identifying Salmonella Rissen, Salmonella Minnesota, and Salmonella Mbandaka strains in both pre- and post-processing areas. Some Salmonella strains persisted across inspections, suggesting they were resident within the facility.
2. Sanitation failures
   • Cleaning protocols were not followed. Investigators observed employees drying sanitized equipment with visibly soiled paper towels and failing to ensure sufficient sanitizer contact time.
   • Food-contact equipment and tools, such as brooms and squeegees, were found with visible debris after cleaning.
   • Incomplete sanitation records were noted for several months, with missing documentation for July and August 2023.
3. Structural deficiencies
   Rainwater entered the facility during production, creating standing water in production and post-processing areas. This posed additional contamination risks to both raw ingredients and finished products.
4. Process control issues
   The company failed to meet required standards for heat treatment of chicken fat, a raw ingredient, to control Salmonella. Documentation for process control parameters was incomplete, and approximately (redacted by FDA) pounds of dog food were produced using inadequately treated chicken fat.
5. Ineffective corrective actions
   Mid America’s responses to FDA Form 483 Inspectional Observations, issued at the conclusion of both inspections, included updates to sanitation procedures, staff training, and facility repairs. However, FDA determined these measures were insufficient to address recurring Salmonella contamination.

FDA comments

The FDA emphasized the critical nature of the violations, noting that the facility’s sanitation and process control deficiencies contributed to the repeated presence of Salmonella in finished pet food. Despite Mid America’s corrective actions, finished product and environmental testing continued to yield positive results for Salmonella after the facility reopened in early 2024.

Mid America has been directed to provide documentation of effective implementation of its corrective actions and undergo reinspection. Failure to adequately address these violations could result in legal action, including product seizure or injunction.

The full warning letter can be viewed here.

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