FDA Inspection
Isotopia Molecular Imaging Ltd (Soreq Site)Isotopia Molecular Imaging Ltd (Soreq Site) – FDA Inspection, Nov 7, 2016
Record Details
This FDA Inspection record concerns Isotopia Molecular Imaging Ltd (Soreq Site), with an inspection on November 7, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- November 7, 2016
- Product Type
- Human Drugs
- People
- Laurimer Kuilan-Torres (Issuing Officer)
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · 969347bf-ab69-461c-974b-9565770463bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996492
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(b)Representative Samples
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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 |
| September 23, 2019 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
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