Option Care Enterprises

CLOSEOUT LETTER Option Care Enterprises MARCS-CMS 538040 — July 01, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 07/10/2020 Regulated Product(s) Drugs