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  5. Healthtex Distributors, Inc. - 654453 - 01/31/2024
  1. Warning Letters

CLOSEOUT LETTER

Healthtex Distributors, Inc. MARCS-CMS 654453 —

Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WLCOL-02
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Natividad R. Elias
Recipient Title
President and Owner
Healthtex Distributors, Inc.

3555 NW 41st ST.
Miami, FL 33142-4310
United States

ybarreto@healthtexusa.com
Issuing Office:
Division of Human and Animal Food Operations East IV

United States

Secondary Issuing Offices

United States

Dear Mr. Elias:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 23-HAFE4-WL-04 dated June 15, 2023. 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/
Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East

 
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