Diversified Pharmacy Inc dba University Compounding Pharmacy

CLOSEOUT LETTER Diversified Pharmacy Inc dba University Compounding Pharmacy MARCS-CMS 470499 — September 12, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Diversified Pharmacy Inc dba University Compounding Pharmacy United States Issuing Office: United States Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139 September 12, 2018 UPS NEXT DAY SIGNATURE REQUIRED Joseph J. McCloskey Owner Diversified Pharmacy, Inc., dba University Compounding Pharmacy 2520 Livernois Road Troy, MI 48083-4703 Dear Mr. McCloskey: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL 2016 DET-07) dated February 26, 2016. 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/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 09/18/2018