Company
CanadaJubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland, Canada – FDA Inspections
Inspection records and compliance data for Jubilant Draximage Inc., dba Jubilant Radiopharma in Kirkland. 6 FDA inspections on record, 1 Form 483, last inspected April 23, 2024.
Company Profile
This profile covers Jubilant Draximage Inc., dba Jubilant Radiopharma based in Kirkland, Canada.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 17, 2013. Last inspected April 23, 2024.
Most cited issue areas
- Equipment for Environmental Control1 inspection
- Investigations of discrepancies, failures1 inspection
- No written record of investigation1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1240367 |
| June 10, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1171562 |
| September 8, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1035441 |
| December 13, 2016 | Not classified | Human Drugs | 1003944 |
| December 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 953137 |
| September 17, 2013 | VAI | Human Drugs · Drug Quality Assurance | 850564 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- Health Canada · 7 inspections · last January 13, 2025
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Jubilant Draximage Inc., dba Jubilant Radiopharma
FEI Number
3009003838
Address
16751 Rte Transcanadienne, Kirkland, Canada
Country
Canada
ID: 107f9ed8-772f-43cd-98dc-3406bee2f884