- Delivery Method:
- VIA Electronic Mail
Recipient NameMr. Douglas L. Dumler
Recipient TitleGeneral Manager
- Option Care Enterprises, Inc.
9140 Guilford Road
Columbia, MD 21046-1811
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
- (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 firstname.lastname@example.org. Please identify your response with FEI: 3012335395 and Warning Letter - WL #523000.
If you have any questions, contact Compliance Officer Juan Jimenez at email@example.com or 518-453-2314 X-1014.
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District