FDA Inspection
Zealand Pharma A/SZealand Pharma A/S – FDA Inspection, Sep 6, 2024
Record Details
This FDA Inspection record concerns Zealand Pharma A/S, with an inspection on September 6, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · b3ceaaa9-3d77-4e74-927f-49ccede785d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1248947
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring: Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.53(b)Shipment to unauthorized persons
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Other FDA inspections of Zealand Pharma A/S
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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