FDA 483 - Cooper Farms, Inc. - March 24, 2011

This FDA Form 483 documents observations made during an inspection of Ft. Recovery Equity, Inc., located at 2351 Wabash Road, Ft. Recovery, OH 45846. The inspection, conducted on March 23 and 24, 2011, focused on the firm's corporate headquarters and egg production operations.

Four observations were noted:

1. **Failure to test the pullet environment for Salmonella Enteritidis (SE) during the required 14 to 16 weeks of age.** In 7 of 12 reviewed flocks from contract growers, environmental SE testing was performed prior to 14 weeks of age. Specific examples include testing at approximately 12, 11, 9, 11, 9, 13, and 13 weeks of age for various pullet hatch dates.

2. **Failure to include provisions in the written SE prevention plan aimed at preventing the introduction or transfer of SE into or among poultry houses.** The plan provided to contract egg growers lacked provisions for preventing cross-contamination via equipment and persons, and did not prohibit employees from owning birds at home.

3. **Failure to include provisions in the written SE prevention plan for monitoring fly activity.** The plan did not specify methods for monitoring fly activity or for implementing control measures when unacceptable levels are observed.

4. **Failure to have a site-specific written SE