Jubilant DraxImage Radiopharmacies, Inc.

CLOSEOUT LETTER Jubilant DraxImage Radiopharmacies, Inc. MARCS-CMS 480877 — June 04, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Wayne Alexander, MBA Recipient Title Director, Quality Jubilant DraxImage Radiopharmacies, Inc. Triad Isotopes Inc. 4205 Vineland Road Suite L1 Orlando , FL 32811 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States (313) 393-8100 Dear Mr. Alexander: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter CMS #480877, dated March 10, 2016, for Triad Isotopes Inc. located at: 712 Westport Road, Kansas City, MO 64111. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. It should be noted that effective September 1, 2017, Triad Isotopes, Inc. sold all of its assets to Jubilant DraxImage Radiopharmacies, Inc., including the “Triad Isotopes” name. 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. Sincerely, /S/ Nicholas F. Lyons Director Compliance Branch Division of Pharmaceutical Quality Operations III Ph: (312) 596-4220 Cc: Pramod Yadav, CEO Jubilant Pharma Holdings Inc. 790 Township Line Rd., Suite 175 Yardley, PA 19067 Content current as of: 06/12/2020 Regulated Product(s) Drugs