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  5. Cosmax Nbt Usa, Inc. - 615933 - 11/30/2023
  1. Warning Letters

CLOSEOUT LETTER

Cosmax Nbt Usa, Inc. MARCS-CMS 615933 —

Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Jay Ahn
Recipient Title
CEO
Cosmax Nbt Usa, Inc.

3366 Miller Park S
Garland, TX 75042-7771
United States

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

United States

Dear Mr. Ahn:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 615933 dated May 03, 2023) issued following an inspection of your beverage manufacturing and distribution facility, located at 3350 Marquis Dr., Garland, TX 75042-7771. 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/
Jessica E. Havranek
Director, Compliance Branch
Human & Animal Food Operations,
West Division 3

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