FDA WARNING_LETTER - Fresh Mushroom Farm Inc - August 17, 2012

The FDA inspected Fresh Mushroom Farm, Inc. at 2301 Cook Road, Imperial, MO, on August 15 & 17, 2012, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Specific deficiencies included a failure to exclude pests and protect food from contamination (21 CFR 110.35(c)), evidenced by widespread rodent activity. The firm also failed to properly cut weeds and grass around the plant that could harbor pests (21 CFR 110.20(a)(1)). Additionally, inadequate hand washing facilities were noted in the food re-packing area (21 CFR 110.37(e)), and the plumbing system was not adequately maintained, leading to standing water from a damaged drain (21 CFR 110.37(b)). The FDA requires prompt corrective action and a written response within fifteen working days detailing steps taken, or reasons for delay and a completion timeline. Failure to comply may result in regulatory actions such as product seizure, injunction, or prosecution.