Country Bakery, LLC – FDA Warning Letter, Jun 24, 2013

On June 19-24, 2013, the FDA inspected Country Bakery, LLC, Lovell, WY, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering bakery/granola products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Buildings and Facilities (21 CFR 110.35, 110.37, 110.20):** * Failure to exclude pests, with significant evidence of rodents and various insects. * Improper use of sanitizing agents (chlorine significantly higher than 200 ppm). * Failure to maintain sanitary conditions (damaged food contact surfaces, duct-taped drainage pipe, broken faucet). * Inadequate cleaning/sanitizing procedures (no cleaning step before sanitizing). * Toilet facilities lacking self-closing doors. * Inadequate pest protection (gaps in windows, doors, roof/wall joints, dead bird/nesting near production). * Failure to properly store equipment, remove litter, or cut weeds/grass that attract pests. * Unsanitary operation of fans blowing dust/insect webbing onto finished products. * Unsealed and damaged