FDA Inspection 750673 — HemoCue AB
The FDA completed an inspection of HemoCue AB on Oct 26, 2011 in Angelholm. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Angelholm (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |