McGuff Compounding Pharmacy Services, Inc.

CLOSEOUT LETTER McGuff Compounding Pharmacy Services, Inc. MARCS-CMS 481444 — August 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: McGuff Compounding Pharmacy Services, Inc. United States Issuing Office: United States 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 Content current as of: 09/17/2018