U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. McGuff Compounding Pharmacy Services, Inc. - 08/17/2018
  1. Warning Letters

CLOSEOUT LETTER

McGuff Compounding Pharmacy Services, Inc.


Recipient:
McGuff Compounding Pharmacy Services, Inc.

United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 

Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road,Irvine, CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417

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