Mason City Cold Storage Company – FDA Warning Letter, Aug 7, 2013

On August 6-7, 2013, the FDA inspected Mason City Cold Storage Company, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) for human food. These violations render the stored food adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was held under insanitary conditions risking contamination.

Specific violations include: 1. **Failure to exclude pests (21 CFR 110.35(c)):** Widespread pest activity was observed. This included numerous apparent excreta pellets (AEP) on and around various food products (oats, flour, macaroni, vegetable oil, refried beans) in dry storage room 4-5. AEP were also found on floors and walls, particularly near holes. Two bats were seen hanging directly over all-purpose flour lots. 2. **Failure to maintain grounds (21 CFR 110.20(a)(1)):** Overgrown grass and weeds around the new freezer building could attract pests. 3. **Failure to maintain facilities in good repair (21 CFR 110.35(a)):** The pallet storage room had at least five holes in the wall with exposed insulation, and a storage space contained out-of-use equipment and refuse. In room 5, a large, approximately