FDA WARNING_LETTER - Centrum Valley Farms, LLP (South Complex) - May 04, 2012

On April 30-May 4, 2012, the FDA inspected Centrum Valley Farms, LLP's shell egg facility in Clarion, Iowa, finding serious violations of 21 CFR Part 118, the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation. These violations render their shell eggs adulterated under section 402(a)(4) of the FD&C Act and in violation of section 361(a) of the PHS Act.

Key violations include: 1. **Inadequate SE Prevention Plan:** The written plan failed to include required measures such as environmental testing of pullets at 14-16 weeks (21 CFR 118.4(a)(2)(i)) and procedures for cleaning/disinfecting positive pullet houses (21 CFR 118.4(a)(3)(ii), (iii)). A revised plan was submitted, which FDA will verify. 2. **Failure to Conduct Timely Environmental Testing:** Pullet environmental testing was conducted outside the 14-16 week timeframe in 14 instances, and laying hen environmental testing was conducted outside the 40-45 week timeframe in 8 instances (21 CFR 118.4(a)(2)(i), 118.5(a)). Proposed corrections involve basing timing on hatch dates. 3.