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  5. D'Andrea Foods, Inc. - 576292 - 09/08/2020
  1. Warning Letters

CLOSEOUT LETTER

D'Andrea Foods, Inc. MARCS-CMS 576292 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Michael D’Andrea
Recipient Title
President and Owner
D'Andrea Foods, Inc.

378 Pleasant St
East Bridgewater, MA 02333-1349
United States

Issuing Office:
Office of Human and Animal Food Operations East - Division 1

United States

Dear Mr. D’Andrea:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to ourWarning Letter CMS # 576292 dated March 15, 2019. Based on our evaluation, it appears that you have addressed the violations contained in thisWarning 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 subsequent inspection or through other means.

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

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