558830
Sheathing Technologies Inc — FEI 1000135740
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Morgan Hill, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |