FDA Inspection
International Isotopes Inc.International Isotopes Inc. – FDA Inspection, Apr 25, 2025
Record Details
This FDA Inspection record concerns International Isotopes Inc., with an inspection on April 25, 2025, issued by the Seattle District Office, covering human drugs.
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ID · a4bfb1f3-32b0-492b-b3c9-7cf1c67152de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1267869
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of International Isotopes Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| December 8, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| October 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2011 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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