FDA WARNING_LETTER - Mikilua Poultry Farm Inc. - September 16, 2011

The FDA inspected Mikilua Poultry Farm Inc.'s four shell egg production facilities in Waianae, Hawaii, from September 12-16, 2011, revealing serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These failures render the firm's shell eggs adulterated under the FFD&C Act Section 402(a)(4) and in violation of the PHS Act Section 361(a). Significant violations included the failure to have a comprehensive written SE Prevention Plan, specifically lacking adequate procedures for rodent and fly monitoring and biosecurity practices for equipment and personnel movement. The firm also failed to prevent wild birds and other animals from entering poultry houses and did not remove vegetation providing pest harborage. Additionally, rodent monitoring methods were inadequate, relying solely on visual inspection, and the environmental sampling plan was deemed inappropriate for the poultry house layout. The firm's submitted corrective action plan was found to lack sufficient detail in several areas. Mikilua Poultry Farm is required to provide a written response within 15 working days detailing specific corrective actions, supporting documentation, and a timeline for any longer-term repairs. Failure to promptly correct these violations may result in FDA regulatory action, including seizure or injunction.