972657
Precise Plastics, Inc. — FEI 3001748889
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fairview, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |