Auro Pharmacies, Inc.

CLOSEOUT LETTER Auro Pharmacies, Inc. MARCS-CMS 608369 — April 11, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 04/14/2023 Regulated Product(s) Drugs