FDA Inspection
Isotopia Molecular Imaging Ltd (Soreq Site)Isotopia Molecular Imaging Ltd (Soreq Site) – FDA Inspection, Nov 8, 2022
Record Details
This FDA Inspection record concerns Isotopia Molecular Imaging Ltd (Soreq Site), with an inspection on November 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 8, 2022
- Product Type
- Drugs
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ID · 4407c1d0-d94a-4292-980d-f12b400ba500
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190553
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Isotopia Molecular Imaging Ltd (Soreq Site)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2019 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
| November 7, 2016 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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