Mytilini Enterprises LLC dba Bedford Pharmacy Inc.

CLOSEOUT LETTER Mytilini Enterprises LLC dba Bedford Pharmacy Inc. MARCS-CMS 486159 — January 11, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 orapharm1_responses@fda.hhs.gov Please identify your correspondence with FEI: 3003687986. If you have any questions, contact Compliance Officer Juan Jimenez at 518-453-2314 X-1014 or juan.jimenez@fda.hhs.gov . Craig W. Swanson For Diana Amador-Toro Program Division director/District Director U.S. Food and Drug Administration OPQO Division I / New Jersey District Content current as of: 01/15/2021 Regulated Product(s) Drugs