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  5. Option Care Enterprises - 538040 - 07/01/2020
  1. Warning Letters

CLOSEOUT LETTER

Option Care Enterprises MARCS-CMS 538040 —

Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
John C. Rademacher
Recipient Title
President and CEO
Option Care Enterprises

3000 Lakeside Drive
Suite 300N
Bannockburn, IL 60015-5405
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

(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.

Sincerely,
/S/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III

 
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