FDA Inspection 558830 — Sheathing Technologies Inc
The FDA completed an inspection of Sheathing Technologies Inc on January 30, 2009 in Morgan Hill, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: 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 |