- Delivery Method:
- UPS Next Day
Recipient NameJohn C. Rademacher
Recipient TitlePresident and CEO
- Option Care Enterprises
3000 Lakeside Drive
Bannockburn, IL 60015-5405
- Issuing Office:
- Division of Pharmaceutical Quality Operations III
- (313) 393-8100
Dear Mr. Rademacher:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated 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 ensure 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
Director Compliance Branch
Division of Pharmaceutical Quality Operations III