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CLOSEOUT LETTER

Nashoba Brook Bakery, LLC MARCS-CMS 532236 — Apr 03, 2019

Nashoba Brook Bakery, LLC - 532236 - 04/03/2019

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
John D. Gates, Stuart J. Witt
Recipient Title
Co-Owner
Nashoba Brook Bakery, LLC

152 Commonwealth Ave.
Concord, MA 01742-2990
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

158-15 Liberty Avenue
Jamaica, NY 11433
United States


Dear Mr. Gates and Mr. Witt:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 532236, issued on September 22, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1