FDA Inspection
Norgine LimitedNorgine Limited – FDA Inspection, Aug 16, 2019
Record Details
This FDA Inspection record concerns Norgine Limited, with an inspection on August 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Emilie Kahn (Issuing Officer)
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ID · 5f3e71d3-f5ab-4a6a-b3bf-9c85662cb5e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099809
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Norgine Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| September 8, 2017 | Not classified | Office of Inspections and Investigations |
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