FDA WARNING_LETTER - Stanton Brothers - August 28, 2013

The FDA inspected Stanton Brothers' shell egg production facility in Centralia, Missouri, on August 27-28, 2013, revealing serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These failures render the firm's shell eggs adulterated under the FD&C Act and in violation of the PHS Act. Significant deficiencies included the failure to conduct environmental SE testing for laying hens (40-45 weeks old) and a lack of documentation for pullet environment SE testing (14-16 weeks old). The firm also failed to implement adequate biosecurity measures, evidenced by pigeons and dogs co-mingling with hens, and did not remove debris providing pest harborage. Furthermore, the facility lacked appropriate monitoring for flies and rodents, and its written SE Prevention Plan was incomplete, missing crucial elements like visitor limitations, cross-contamination prevention, and cleaning/disinfection procedures. Record-keeping for biosecurity measures was also deficient. The firm's September 16, 2013, response was deemed inadequate for several points, lacking sufficient detail or failing to address core issues like determining hen age for testing. Stanton Brothers must promptly correct these violations and respond within 15 working days with specific corrective actions and supporting documentation, including an updated SE prevention plan. Failure to comply may result in FDA regulatory actions such as administrative enforcement, seizure, or injunction.