- Delivery Method:
- UPS Next Day
Recipient NameStanley S. Kent, R.Ph.
Recipient TitleChief Pharmacy Officer
- Michigan Medicine
1500 E. Medical Center Drive
Ann Arbor, MI 48109-5008
- Issuing Office:
- Center for Drug Evaluation and Research
300 River Place
Detroit, MI 48207
- (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.
Nicholas F. Lyons
Division of Pharmaceutical Quality Operations III