Fallon Wellness Pharmacy, L.L.C.

CLOSEOUT LETTER Fallon Wellness Pharmacy, L.L.C. MARCS-CMS 485889 — December 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS NEXT DAY DELIVERY Product: Drugs Recipient: Recipient Name Peter L. Fallon Recipient Title Owner Fallon Wellness Pharmacy, L.L.C. 1057 Troy-Schenectady Road Latham , NY 12110-1002 United States Issuing Office: Center for Drug Evaluation and Research United States Dear Mr. Fallon: 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 # NYK-2016-23, dated February 1, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 assure 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. Sincerely, /S/ Diana Amador-Toro Program Division Director OPQO Division 1 New Jersey District Office Content current as of: 02/04/2019 Regulated Product(s) Drugs