International Isotopes Inc.
Form 483 issued April 25, 2025 · Idaho Falls, Idaho
- Inspection
- Apr 21 – Apr 25, 2025
- Investigator
- Khoa Nathan V. Tran
- Observations
- 3
- Pages
- 6
- FEI number
- 3003350319
In short: On April 25, 2025, FDA issued a Form 483 with 3 observations to International Isotopes Inc. in Idaho Falls, Idaho (FEI 3003350319) after an inspection that ran Apr 21 – Apr 25, 2025. The investigator was Khoa Nathan V. Tran. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The accuracy and reproducibility of test methods have not…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training and experience…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmInternational Isotopes Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Isotopes Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected International Isotopes Inc.?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Apr 21 – Apr 25, 2025. Each investigator has a profile showing what they cite most.
When was International Isotopes Inc. inspected by FDA?
The inspection ran Apr 21 – Apr 25, 2025, and the Form 483 is dated April 25, 2025.
How do I get the full Form 483 for International Isotopes Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.