FDA Inspection
Jubilant Draximage Inc., dba Jubilant RadiopharmaJubilant Draximage Inc., dba Jubilant Radiopharma – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Jubilant Draximage Inc., dba Jubilant Radiopharma, with an inspection on December 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 17, 2015
- Product Type
- Drugs
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ID · 23ad4614-9e19-4ea5-98ac-2bc03b0981ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953137
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Jubilant Draximage Inc., dba Jubilant Radiopharma
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2016 | Not classified | Office of Inspections and Investigations | |
| September 17, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Jubilant Draximage Inc., dba Jubilant Radiopharma
- FDA Inspection 1240367 - 2024-04-23
- FDA Inspection 1171562 - 2022-06-10
- FDA Inspection 1035441 - 2017-09-08
- FDA Inspection 1003944 - 2016-12-13
- FDA Inspection 850564 - 2013-09-17
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