FDA Inspection
Isotopia Molecular Imaging Ltd (Soreq Site)Isotopia Molecular Imaging Ltd (Soreq Site) – FDA Inspection, Sep 23, 2019
Record Details
This FDA Inspection record concerns Isotopia Molecular Imaging Ltd (Soreq Site), with an inspection on September 23, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 23, 2019
- Product Type
- Human Drugs
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ID · 628188a6-ef35-49d6-9674-c10861e3a3df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102462
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 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 |
|---|---|---|---|
| November 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2016 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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