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  5. Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - 555295 - 04/04/2022
  1. Warning Letters

CLOSEOUT LETTER

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy MARCS-CMS 555295 —

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

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