International Isotopes Inc.
FDA inspection history in Idaho Falls, Idaho, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Idaho Falls, Idaho.
- 2019The longest 483 on file: 6 observations over 6 pages at Idaho Falls, Idaho.
- 2025One Form 483, at Idaho Falls, Idaho.
Cited most
Across all International Isotopes observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete International Isotopes file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Idaho Falls, Idaho
Two Form 483s · 2019 to 2025 · 9 observations
Latest: Form 483, Apr 25, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-25 | 483 Form 483 | Idaho Falls, Idaho | 3 | $99 |
| 2019-05-10 | 483 Form 483 | Idaho Falls, Idaho | 6 | $99 |
Investigators on these documents
FEI number 3003350319 · most recent document Apr 25, 2025
About International Isotopes Inc.
How many FDA Form 483s has International Isotopes Inc. received?
FDA Intel has 2 Form 483s on file for International Isotopes Inc.; the most recent is dated Apr 25, 2025.
When was International Isotopes Inc. last inspected by FDA?
The most recent FDA inspection document on file for International Isotopes Inc. is a Form 483 dated Apr 25, 2025, for the site in Idaho Falls, Idaho.
What did FDA cite at International Isotopes Inc.?
The regulations cited most in the observations on file for International Isotopes Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.