FDA Inspection
Guidewire Technologies, Inc.Guidewire Technologies, Inc. – FDA Inspection, Aug 12, 2010
Record Details
This FDA Inspection record concerns Guidewire Technologies, Inc., with an inspection on August 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guidewire Technologies, Inc.
- Inspection Date
- August 12, 2010
- Product Type
- Devices
View Company Profile
ID · 9434e848-ce91-42a9-942c-9130b9515983
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guidewire Technologies, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | Not classified | New England District Office | |
| March 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 22, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Guidewire Technologies, Inc.
- FDA Inspection 1267030 - 2025-03-28
- FDA Inspection 963384 - 2016-03-10
- FDA Inspection 903156 - 2014-11-19
- FDA Inspection 794870 - 2012-08-16
- FDA Inspection 644227 - 2010-01-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.