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
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Content current as of:
08/14/2019
