- Delivery Method:
- UPS Next Day
Recipient NameWayne Alexander, MBA
Recipient TitleDirector, Quality
- Jubilant DraxImage Radiopharmacies, Inc.
- Triad Isotopes Inc.
4205 Vineland Road
Orlando, FL 32811
- Issuing Office:
- Division of Pharmaceutical Quality Operations III
- (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.
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