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  5. Option Care Enterprises, Inc. dba Option Care - 527394 - 12/20/2019
  1. Warning Letters

CLOSEOUT LETTER

Option Care Enterprises, Inc. dba Option Care MARCS-CMS 527394 —

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