FDA Inspection 557517 — Guidewire Technologies, Inc.
The FDA completed an inspection of Guidewire Technologies, Inc. on November 5, 2008 in Salem, NH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 5, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |