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CLOSEOUT LETTER

Michigan Medicine MARCS-CMS 518396 — Jun 13, 2019

Michigan Medicine - 518396 - 06/13/2019

Delivery Method:
UPS Next Day
Product:
Drugs

Recipient:
Recipient Name
Stanley S. Kent, R.Ph.
Recipient Title
Chief Pharmacy Officer
Michigan Medicine

1500 E. Medical Center Drive
Ann Arbor, MI 48109-5008
United States

Issuing Office:
Center for Drug Evaluation and Research

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Kent:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case #518396, September 28, 2017]. 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