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

Source: https://www.keypedia.com/records/warning_letter/nashoba-brook-bakery-llc/387f987e-2db6-4f64-b538-490328f1e847

> FDA WARNING_LETTER for Nashoba Brook Bakery, LLC on June 08, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nashoba Brook Bakery, LLC
- Inspection Date: 2017-06-08
- Product Type: Food
- Office Name: New York District Office
- Summary: 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

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/nashoba-brook-bakery-llc/31f6ff55-6a4e-41b7-a7dd-3e5730e21a6b

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d