The findings of a resident strain of Salmonella Enteritidis (SE) in a Georgia shell egg farm and processing facility and serious violations of the shell egg regulation (21 CFR 118) during an FDA investigation caused inspectors to render shell eggs adulterated and issue a Form 483. The agency’s ensuing “review of the inspectional findings, the analytical findings, and your responses (describing the corrective actions)” led to the further issuance of a warning letter due to “FDA’s continued concerns.”
The specific allegations in the warning letter included detail of the ineffective compliance with the regulation resulting in the serious violations were:
- A resident strain of Salmonella was found in the facility and included some isolates that matched clinical isolates. The pathogen was detected by swab samples taken in the poultry houses which tested positive for SE. Additionally, SE had been previously found across multiple years in these areas, and the species isolates matched several clinical isolates in reference databases.
- Steps were not taken to prevent transfer of SE into and among the poultry houses. Stray animals were not prevented from entering the areas, and gaps and holes were observed in exterior walls and where pipes traveled through the walls. Cleaning and disinfection protocols were not effectively implemented between flocks, with all manure not removed and no verification swabbing conducted. Additionally, debris (including spilled feed, discarded food, unused equipment, and excess vegetation) was not removed in/around poultry houses which could provide pest harborage areas. As a likely outcome, live and dead rodents and flies were observed.
Interestingly, the observations of this warning letter fall right into the first two observations listed among the Top 10 in our FDA Says article (above), with the shell egg operation noncompliant in #1 Pest control and #2 Sanitary operations and maintenance. Food industry facilities – of all industry segments – are well-advised to take this as a Lesson Learned.
