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  5. Option Care Enterprises, Inc. - 523000 - 04/23/2020
  1. Warning Letters


Option Care Enterprises, Inc. MARCS-CMS 523000 —

Delivery Method:
VIA Electronic Mail

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
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District

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