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  5. Entia Biosciences, Inc. - 610493 - 04/29/2021
  1. Warning Letters

CLOSEOUT LETTER

Entia Biosciences, Inc. MARCS-CMS 610493 —

Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Timothy A. Timmins
Recipient Title
President
Entia Biosciences, Inc.

8245 SW 166th Place
Beaverton, OR 97007
United States

Issuing Office:
Division of Human and Animal Food Operations West VI

United States

Dear Mr. Timmins:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 610493, dated January 6, 2021. 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/
Miriam R. Burbach
District Director
Program Division Director

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