Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

CLOSEOUT LETTER Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy MARCS-CMS 555295 — April 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Nasim P. Barrack Recipient Title Chief Consultant Pharmacist Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 41538 Eastman Dr. STE A Murrieta , CA 92562-8007 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Mr. Barrack: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL# 555295, dated September 19, 2018). Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. 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: 04/19/2022 Regulated Product(s) Drugs