Company
IsraelIsotopia Molecular Imaging Ltd (Soreq Site), Yavne, Israel – FDA Inspections
Inspection records and compliance data for Isotopia Molecular Imaging Ltd (Soreq Site) in Yavne. 3 FDA inspections on record, 2 Form 483s, last inspected November 08, 2022.
Company Profile
This profile covers Isotopia Molecular Imaging Ltd (Soreq Site) based in Yavne, Israel.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 7, 2016. Last inspected November 8, 2022.
Most cited issue areas
- Scientifically sound laboratory controls2 inspections
- Absence of Written Procedures1 inspection
- Buildings not maintained in good state of repair1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1190553 |
| September 23, 2019 | VAI | Human Drugs · New Drug Evaluation | 1102462 |
| November 7, 2016 | VAI | Human Drugs · Generic Drug Evaluation | 996492 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Isotopia Molecular Imaging Ltd (Soreq Site)
FEI Number
1000234390
Address
Soreq Nuclear Research Centre Building 54, 4111, Nachal Soreq Rd., Yavne, Israel
Country
Israel
ID: de2752ce-03f6-48d0-87a1-77ebaa6fbcc8