University Rx Specialists Inc

CLOSEOUT LETTER University Rx Specialists Inc MARCS-CMS 495985 — December 11, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: SIGNATURE CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Joseph Grasela, RPh Recipient Title President/Owner University Rx Specialists Inc University Compounding Pharmacy 1875 3rd Avenue San Diego , CA 92101-2604 United States Issuing Office: Center for Drug Evaluation and Research 19701 Fairchild Irvine , CA 92612-2506 United States 949-608-2900 Dear Mr. Grasela: 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 # 51-16, dated September 28, 2016. We acknowledge that your firm receives valid prescriptions for individually-identified patients for all of the drug products you produce. 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: 08/14/2019 Regulated Product(s) Drugs