FDA Inspection 1055264 — HemoCue AB
The FDA completed an inspection of HemoCue AB on May 31, 2018 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 31, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Angelholm (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |