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  5. University Rx Specialists Inc - 495985 - 12/11/2018
  1. Warning Letters

CLOSEOUT LETTER

University Rx Specialists Inc MARCS-CMS 495985 —

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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