Option Care Enterprises, Inc.

CLOSEOUT LETTER Option Care Enterprises, Inc. MARCS-CMS 523000 — April 23, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Douglas L. Dumler Recipient Title General Manager Option Care Enterprises, Inc. 9140 Guilford Road Suite K Columbia , MD 21046-1811 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States (973) 331-4900 Dear Mr. Dumler: 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 #523000) dated July 20, 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. Please send your electronic inquiries to orapharm1_responses@fda.hhs.gov . Please identify your response with FEI: 3012335395 and Warning Letter - WL #523000. If you have any questions, contact Compliance Officer Juan Jimenez at juan.jimenez@fda.hhs.gov or 518-453-2314 X-1014. Diana Amador-Toro /S/ Program Division Director/District Director U.S. Food and Drug Administration OPQO Division I / New Jersey District Content current as of: 06/17/2020 Regulated Product(s) Drugs