FDA WARNING_LETTER - Granja La Cabana - December 10, 2014

On December 2-10, 2014, the FDA inspected Granja La Cabaña, Inc.'s shell egg production facility in Utuado, Puerto Rico, finding serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render their shell eggs adulterated under the FD&C Act and in violation of the PHS Act.

Key violations include: 1. **Incomplete SE Prevention Plan:** The submitted plan lacked required sections on pullets and refrigeration procedures (21 CFR 118.4(a), 118.4(e)). 2. **Inadequate Rodent and Fly Monitoring:** The facility failed to use appropriate monitoring methods like mechanical traps/glueboards for rodents (21 CFR 118.4(c)(1)) or spot cards/sticky traps for flies (21 CFR 118.4(c)(2)). The submitted plan also lacked methods for achieving satisfactory fly control. 3. **Insufficient Biosecurity Measures:** * Failure to limit visitors (open front gate) (21 CFR 118.4(b)(1)). * No practices to prevent cross-contamination between poultry houses (e.g., boot cleaning, foot dips) (21 CFR 118.4(b)(3)).