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  1. Warning Letters

CLOSEOUT LETTER

UMZU, LLC MARCS-CMS 611501 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Michael J. Dobson
Recipient Title
CEO
UMZU, LLC

6325 Spine Rd
Boulder, CO 80301-3321
United States

quality@umzu.com
Issuing Office:
Division of Human and Animal Food Operations West IV

United States

Secondary Issuing Offices

United States

Dear Mr. Dobson:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 611501, dated October 14, 2022. 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/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4

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