FDA Inspection 829270 — Novo Nordisk A/S - 25A-B
The FDA completed an inspection of Novo Nordisk A/S - 25A-B on Mar 19, 2013 in Hillerod. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hillerod (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |