FDA Inspection
Norgine LimitedNorgine Limited – FDA Inspection, Jun 20, 2025
Record Details
This FDA Inspection record concerns Norgine Limited, with an inspection on June 20, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2aeeddba-0285-4355-81e2-a10ae8601e37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1273643
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Norgine Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2017 | Not classified | Office of Inspections and Investigations |
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