Michigan Medicine

CLOSEOUT LETTER Michigan Medicine MARCS-CMS 518396 — June 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 06/21/2019 Regulated Product(s) Drugs