FDA WARNING_LETTER - C.C. & Son Farms, Incorporated - April 26, 2012

The FDA inspected C.C. & Son Farms, Incorporated's shell egg production facility in Ripon, California, on April 23, 24, and 26, 2012. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118), rendering the firm's shell eggs in violation of the Public Health Service Act and adulterated under the Federal Food, Drug, and Cosmetic Act. Significant violations included the failure to conduct SE environmental testing using an equivalent method (21 CFR 118.8(a)), an inadequate written SE Prevention Plan lacking refrigeration requirements (21 CFR 118.4), and a failure to maintain records for biosecurity training (21 CFR 118.10(a)(3)(i)). Additionally, the firm failed to remove debris providing pest harborage (21 CFR 118.4(c)(3)), and records lacked farm location (21 CFR 118.10(b)(1)) and activity times (21 CFR 118.10(b)(2)). The firm was informed of these issues via an FDA-483. Despite verbal commitments to correct issues, no written response or supporting documentation was submitted. The FDA requires prompt corrective action within fifteen working days, including an updated SE Prevention Plan, environmental sampling plan, biosecurity training records, and evidence of debris removal. Failure to comply may result in regulatory actions such as seizure or injunction.