FDA Inspection 547150 — Besmed Health Business Corporation
The FDA completed an inspection of Besmed Health Business Corporation on Oct 30, 2008 in New Taipei City. 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
- Oct 30, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Taipei City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |