FDA WARNING_LETTER - Boyd Mahrt and Ingrid Mahrt - September 28, 2012

The FDA inspected Boyd and Ingrid Mahrt's shell egg production facility in Petaluma, California, from September 17-28, 2012, revealing serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These failures render their shell eggs adulterated under the FD&C Act and in violation of the PHS Act. Significant deficiencies included the lack of a comprehensive written SE prevention plan, specifically failing to address cleaning and disinfection of the pullet environment after an SE-positive test, as required by 21 CFR 118.4(a)(3). The firm also failed to implement appropriate rodent monitoring methods, lacking threshold levels for unacceptable activity and control measures (21 CFR 118.4(c)(1)). Environmental testing for SE was not conducted within the required 14-16 week pullet age timeframe (21 CFR 118.4(a)(2)(i)) and 40-45 week laying hen age timeframe (21 CFR 118.5(a)). Furthermore, the facility failed to maintain adequate records for pest control (21 CFR 118.10(a)(3)(ii)) and did not include the farm's name, location, or activity times on required records (21 CFR 118.10(b)(1) and (b)(2)). The FDA requires prompt corrective action, including an updated SE prevention plan and monitoring records, with a written response due within fifteen working days to avoid potential regulatory actions like seizure or injunction.