FDA Inspection 963384 — Guidewire Technologies, Inc.
The FDA completed an inspection of Guidewire Technologies, Inc. on Mar 10, 2016 in Salem, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 10, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |