- Delivery Method:
- VIA EMAIL CONFIRMED DELIVERY
Recipient NameMr. Nasim P. Barrack
Recipient TitleChief Consultant Pharmacist
- Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
41538 Eastman Dr.
Murrieta, CA 92562-8007
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV