FDA Inspection
International Isotopes Inc.International Isotopes Inc. – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns International Isotopes Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 92bbb9e3-a01f-4f12-a476-7a5dd7e80b02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034270
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
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Other FDA inspections of International Isotopes Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2025 | OAI | Seattle District Office | Drug Quality Assurance |
| May 10, 2019 | 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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