Option Care Enterprises, Inc. dba Option Care

CLOSEOUT LETTER Option Care Enterprises, Inc. dba Option Care MARCS-CMS 527394 — December 20, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Kimberly I. Young Recipient Title Director of Operations Option Care Enterprises, Inc. dba Option Care 9601 Baptist Health Drive Suite 330 Little Rock , AR 72205-6323 United States Issuing Office: Division of Pharmaceutical Quality Operations II (PHRM2) United States Ms. Young: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [WL #527394 dated September 12, 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. If you have questions regarding the contents of this letter, you may contact Rebecca A. Asente, Compliance Officer, via (504) 846-8104 or Rebecca.asente@fda.hhs.gov . Sincerely, /S/ John W. Diehl, M.S Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 12/30/2019 Regulated Product(s) Drugs