FDA WARNING_LETTER - David C. Kauffman - June 21, 2013

The FDA inspected David C. Kauffman's shell egg production facility in Kalona, IA, from June 19-21, 2013, identifying significant violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render the shell eggs adulterated under the FD&C Act and in violation of the PHS Act. The firm failed to have a comprehensive written SE prevention plan (21 CFR 118.4), lacking critical details on chick procurement, pullet testing, cross-contamination prevention, animal exclusion, employee bird-keeping, vegetation removal, cleaning/disinfection, and specific methods for rodent/fly control and refrigeration. Furthermore, the firm failed to implement its existing plan, evidenced by unrecorded refrigeration temperatures and inconsistent fly monitoring. Eggs were not consistently held at or below 45°F ambient temperature beginning 36 hours after lay. Cross-contamination risks were identified due to uncleaned equipment moved between poultry houses. Significant record-keeping deficiencies were noted (21 CFR 118.10), including failure to document rodent monitoring, absence of farm name/location on records, missing dates/times for activities, and an undated/unsigned SE prevention plan. The FDA requires prompt corrective action, including a revised SE prevention plan and documentation, within 15 working days to avoid further regulatory action such as seizure or injunction.