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  5. A&Z Pharmaceutical Inc - 645101 - 05/24/2024
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CLOSEOUT LETTER

A&Z Pharmaceutical Inc MARCS-CMS 645101 —

Product:
Dietary Supplements

Recipient:
Recipient Name
Emma Qingbo Li Xu
Recipient Title
Chairwoman/CEO
A&Z Pharmaceutical Inc

180 Oser Ave., Suite 300
Hauppauge, NY 11788-3709
United States

emmaerwin@azpharmaceutical.com
Issuing Office:
Division of Human and Animal Food Operations East I

United States

Secondary Issuing Offices

United States


Dear Ms. Li Xu:

The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 645101, issued on June 1, 2023. 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/
Lillian C. Aveta
Acting Director, Compliance Branch (ADCB)
Office of Human and Animal Food Operations East Division 1

 
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