FDA Inspection 844111 — Cheen Houng Enterprise Co., Ltd.
The FDA completed an inspection of Cheen Houng Enterprise Co., Ltd. on Aug 8, 2013 in Shulin. 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
- Aug 8, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shulin (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |