FDA Inspection
Jubilant Draximage Inc., dba Jubilant RadiopharmaJubilant Draximage Inc., dba Jubilant Radiopharma – FDA Inspection, Jun 10, 2022
Record Details
This FDA Inspection record concerns Jubilant Draximage Inc., dba Jubilant Radiopharma, with an inspection on June 10, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 10, 2022
- Product Type
- Drugs
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ID · 9eec5bd4-8c1b-4c69-a412-0ff40462ae65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171562
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| September 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2016 | Not classified | Office of Inspections and Investigations | |
| December 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1035441 - 2017-09-08
- FDA Inspection 1003944 - 2016-12-13
- FDA Inspection 953137 - 2015-12-17
- FDA Inspection 850564 - 2013-09-17
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