Company
United StatesGuidewire Technologies, Inc., Salem, NH – FDA Inspections
Inspection records and compliance data for Guidewire Technologies, Inc. in Salem, New Hampshire. 7 FDA inspections on record (1 OAI), last inspected March 28, 2025.
Company Profile
This profile covers Guidewire Technologies, Inc. based in Salem, New Hampshire, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 5, 2008. Last inspected March 28, 2025.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Management review - defined interval, sufficient frequency2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 28, 2025 | Not classified | Medical Devices & Rad Health | 1267030 |
| March 10, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 963384 |
| November 19, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 903156 |
| August 16, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 794870 |
| August 12, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678089 |
| January 22, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 644227 |
| November 5, 2008 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 557517 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Guidewire Technologies, Inc.
FEI Number
1221806
Address
26 Keewaydin Dr, Salem, New Hampshire 03079, United States
Country
United States
ID: 7bc5f458-8c4c-4b85-8a6a-9ea29842d8aa