FDA Inspection 926770 — Pihsiang Machinery Mfg Co Ltd
The FDA completed an inspection of Pihsiang Machinery Mfg Co Ltd on May 7, 2015 in Hsinfeng Hsiang. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hsinfeng Hsiang (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |