FDA Inspection 1248947 — Zealand Pharma A/S
The FDA completed an inspection of Zealand Pharma A/S on September 6, 2024 in Soborg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Soborg (Denmark)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7409 | 21 CFR 312.53(b) | Shipment to unauthorized persons |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |