FDA WARNING_LETTER - Nashoba Brook Bakery, LLC - June 08, 2017

The FDA inspected Nashoba Brook Bakery, LLC from May 25 to June 8, 2017, observing serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) and issuing a Form FDA-483. No written response to the FDA-483 was received. These conditions render food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Violations include: 1. **Adulterated Foods:** * Failure to minimize microbial growth/contamination (21 CFR 110.80(b)(2)): Observed allergen cross-contamination (e.g., Pepper Jack dough remnants on "cleaned" non-dairy equipment, stacked barrels with residue, uncleaned equipment between allergen products). * Failure to maintain equipment and utensils in acceptable condition (21 CFR 110.80(b)(1)): Observed encrusted debris on dough mixer, dough residue on plastic barrels/totes, and a 1" dough clump in a barrel crack. * Failure to maintain sanitary facilities (21 CFR 110.35(a)): Observed caked debris on ceiling vents and sprinkler heads, stained/missing ceiling tiles, debris on wooden bread peels, flour buildup on surfaces, and damaged flooring. * Failure to protect against contamination from