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  5. Auro Pharmacies, Inc. - 608369 - 04/11/2023
  1. Warning Letters

CLOSEOUT LETTER

Auro Pharmacies, Inc. MARCS-CMS 608369 —

Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Dr. Nayan Patel
Recipient Title
CEO
Auro Pharmacies, Inc.

520 W La Habra Blvd.
La Habra, CA 90631
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Dear Dr. Patel:

The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letters (WL 8-17 dated December 13, 2016, and WL CMS 608369 dated June 3, 2020). We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in the warning letters.

You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. 


Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

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