FDA Inspection 848688 — Pacific Hospital Supply Co., Ltd
The FDA completed an inspection of Pacific Hospital Supply Co., Ltd on Aug 29, 2013 in Miaoli County. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miaoli County (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |