Option Care, Inc.

CLOSEOUT LETTER Option Care, Inc. MARCS-CMS 454500 — April 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Reference #: 2015-DAL-WL-29 Product: Drugs Recipient: 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 . Sincerely, /S/ Mark W. Rivero for LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II cc: Amy F. Groves Director of Operations Option Care, Inc. 9030 Kirby Drive Houston, Texas 77054 Content current as of: 05/21/2019 Regulated Product(s) Drugs