Company
United StatesInternational Isotopes Inc., Idaho Falls, ID – FDA Inspections
Inspection records and compliance data for International Isotopes Inc. in Idaho Falls, Idaho. 5 FDA inspections on record (2 OAI), 3 Form 483s, last inspected April 25, 2025.
Company Profile
This profile covers International Isotopes Inc. based in Idaho Falls, Idaho, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 3
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 0
First inspected July 22, 2011. Last inspected April 25, 2025.
Most cited issue areas
- Investigations of discrepancies, failures3 inspections
- Procedures for non-sterile drug products3 inspections
- Approve or reject procedures or specs2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1267869 |
| May 10, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1090194 |
| December 8, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1034270 |
| October 19, 2012 | VAI | Human Drugs · Drug Quality Assurance | 803415 |
| July 22, 2011 | OAI | Human Drugs · Unapproved and Misbranded Drugs | 735266 |
FDA documents
Form 483s (2)
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Company Information
Name
International Isotopes Inc.
FEI Number
3003350319
Address
4137 Commerce Cir, Idaho Falls, Idaho 83401, United States
Country
United States
ID: 45d80b73-be9e-40fb-978b-66683f25c070