FDA Inspection 638732 — Cheen Houng Enterprise Co., Ltd.
The FDA completed an inspection of Cheen Houng Enterprise Co., Ltd. on Dec 17, 2009 in Shulin. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shulin (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |