FDA Inspection 704481 — Well-Life Healthcare Limited
The FDA completed an inspection of Well-Life Healthcare Limited on Dec 2, 2010 in New Taipei City. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 2, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Taipei City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |