CLOSEOUT LETTER

Jubilant DraxImage Radiopharmacies, Inc. MARCS-CMS 480877 — June 04, 2020

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