FDA WARNING_LETTER - Finca Cojobas, Inc. - May 04, 2012

An FDA inspection of Finca Cojobas, Inc.'s shell egg production facility from April 16 to May 4, 2012, revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These failures render the firm's shell eggs adulterated under the Federal Food, Drug, and Cosmetic Act and in violation of the Public Health Service Act. Key deficiencies included the SE prevention plan's failure to require pullets raised under SE monitored conditions (21 CFR 118.4(a)), lack of measures for limiting visitors (21 CFR 118.4(b)(1)), and inadequate procedures for monitoring rodents (21 CFR 118.4(c)(1)) and flies (21 CFR 118.4(c)(2)). The firm also failed to prevent stray animals from entering poultry houses (21 CFR 118.4(b)(4)), remove pest-harboring debris (21 CFR 118.4(c)(3)), and implement cross-contamination prevention practices (21 CFR 118.4(b)(3)). Operational violations included failing to hold and transport eggs at or below 45°F (21 CFR 118.4(e)) and not performing required environmental SE testing at 40-45 weeks of age (21 CFR 118.5(a)) or after molting (21 CFR 118.5(b)). Significant record-keeping failures were also identified under 21 CFR 118.10, including lack of documentation for SE monitored pullets, refrigeration compliance, on-site plan storage, proper record signatures, and retention periods. The firm must respond within fifteen working days detailing corrective actions. Failure to promptly correct these violations could result in regulatory actions like seizure or injunction, and the assessment of re-inspection fees.