Delivery Method: VIA Electronic Mail Product: Drugs Recipient:
Recipient Name
Charles J. Fanaras
Recipient Title
President
Mytilini Enterprises LLC dba Bedford Pharmacy Inc.
209 Route 101
Bedford, NH 03110-5440
United States
Issuing Office: OPQO Division I / New Jersey District
United States
(973) 331-4900
Dear Mr. Fanaras:
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 # 486159), dated May 18, 2016. 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.
Send your communications to [email protected] Please identify your correspondence with FEI: 3003687986.
If you have any questions, contact Compliance Officer Juan Jimenez at 518-453-2314 X-1014 or [email protected].
Craig W. Swanson
For Diana Amador-Toro
Program Division director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
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Content current as of:
01/15/2021
