FDA Inspection
International Isotopes Inc.International Isotopes Inc. – FDA Inspection, May 10, 2019
Record Details
This FDA Inspection record concerns International Isotopes Inc., with an inspection on May 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 8f0580ee-5eaa-4870-a53c-007817419334
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090194
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of International Isotopes Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2025 | OAI | Seattle District Office | Drug Quality Assurance |
| 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 |
Other documents for International Isotopes Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.