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  5. Option Care, Inc. - 454500 - 04/26/2018
  1. Warning Letters


Option Care, Inc. MARCS-CMS 454500 —

Delivery Method:
UPS Overnight
Reference #:

Recipient Name
John C. Rademacher
Recipient Title
Chief Executive Officer
Option Care, Inc.

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

Issuing Office:
Center for Drug Evaluation and Research

United States

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 [Ref: 2015-DAL-WL-29] issued on August 27, 2015, following our inspection of your facility, Option Care, Inc. (formerly Walgreens Infusion Services), located at 9030 Kirby Drive, Houston, Texas 77054, from November 4, 2014 to November 25, 2014. 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.

If you have any questions regarding this letter, please contact Mr. John Diehl, Director, Compliance Branch, at 214-253-5288 or via e-mail at John.Diehl@fda.hhs.gov.

Mark W. Rivero
LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

Amy F. Groves
Director of Operations
Option Care, Inc.
9030 Kirby Drive
Houston, Texas 77054

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