CLOSEOUT LETTER
McGuff Compounding Pharmacy Services, Inc. MARCS-CMS 481444 —
- Recipient:
- McGuff Compounding Pharmacy Services, Inc.
United States
- Issuing Office:
United States
|
|
|
|
Division of Pharmaceutical Quality Operations IV |
August 17, 2018
Ronald M. McGuff, President/CEO
McGuff Compounding Pharmacy Services, Inc.
2921 West MacArthur Blvd., Suite 142
Santa Ana, CA 92704-7944
Dear Mr. McGuff:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL# 6-16) dated November 13, 2015. From May 25, 2017, to June 2, 2017, an FDA investigator conducted an inspection of your facility, McGuff Compounding Pharmacy Services, Inc., located at 2921 West MacArthur Blvd., Suite 142, Santa Ana, CA 92704-7944. 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 assure 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