- Delivery Method:
- VIA UPS
Recipient NameKimberly I. Young
Recipient TitleDirector of Operations
- Option Care Enterprises, Inc. dba Option Care
9601 Baptist Health Drive
Little Rock, AR 72205-6323
- Issuing Office:
- Division of Pharmaceutical Quality Operations II (PHRM2)
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.firstname.lastname@example.org.
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,