FDA WARNING_LETTER - Forsman Farms, Inc - April 15, 2011

On April 12-15, 2011, the FDA inspected Forsman Farms, Inc.'s shell egg production facility in Howard Lake, Minnesota, and found serious violations of the Prevention of Salmonella enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR 118). These violations render the shell eggs adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) and in violation of section 361(a) of the Public Health Service Act (42 U.S.C. § 264(a)).

Key violations include: 1. **Failure to achieve satisfactory rodent control (21 CFR 118.4(c)(1))**: Despite unacceptable rodent activity (rodent index exceeding (b)(4)) between September 29, 2010, and March 23, 2011, the firm failed to use appropriate control methods. Their proposed correction of changing the threshold for corrective action and requiring (b)(4) consecutive weeks of exceeding the index before action was deemed inadequate by the FDA. 2. **Failure to procure or raise SE-monitored pullets (21 CFR 118.4(a))**: Pullets for flock #105