Jeff Mlsna – FDA Warning Letter, Jun 11, 2013

The FDA inspected Jeff Mlsna's shell egg production facility in Cashton, Wisconsin, on June 10-11, 2013, and found significant violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render the shell eggs adulterated under the FD&C Act and in violation of the PHS Act.

Key violations include: 1. **Failure to conduct environmental SE testing at the required age:** Testing was performed when hens were 32 weeks old, not the required 40-45 weeks (21 CFR 118.5(a)). 2. **Failure to fully implement the SE prevention plan for fly control:** The plan required weekly sticky trap counts, but only monthly visual observations were conducted (21 CFR 118.4). 3. **Failure to monitor for rodents by appropriate methods:** The procedure lacked counting/tracking of rodent levels and a defined threshold for unacceptable activity or corrective actions (21 CFR 118.4(c)(1)). 4. **Failure to maintain records of rodent and fly monitoring:** Pest control monitoring activities were not routinely documented (21 CFR 118.10(a)(3)(ii)).

The FDA also commented on the use of an unvalidated sampling method for SE environmental testing and an excessive egg cooler temperature policy.