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Scientist at an egg farm laboratory.

FDA Issues Warning Letter to Egg Farm for SE Prevention Plan Violations and Biosecurity Failures

A shell egg farm and processing facility being inspected by the FDA to determine compliance to the Shell Egg Regulation (21 CFR Part 118) was found to be out of compliance with the requirement for a written Salmonella Enteritidis (SE) Prevention Plan. Specifically, it was found that the facility did not have a written plan to assure that the pullets (young hens) are controlled for SE, either through monitoring or being raised in SE-monitored conditions. This was evidenced by eggs stored in coolers at temperatures exceeding 45°F; SE testing of the environment in the poultry houses not performed according to the regulation; and records were not maintained.

Additionally, the facility did not have biosecurity to prevent the introduction or transfer of SE into or among the poultry houses. The biosecurity provision requires that there be limitations on visitors to protect against cross-contamination and preventions against the entrance of stray animals, among other factors. These were not in evidence as the FDA inspector observed gaps that could permit the entry of pests and gaps in the pest control program including: neither fly presence nor rodent bait consumption were  being monitored and debris and vegetation around the poultry houses could permit pest harborage. Additionally, cleaning and disinfection procedures were not in place.

Reviewing FDA warning letters for noncompliance observations can help other facilities stay in compliance and avoid getting a 483 or warning letter themselves.


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