FDA Inspection
Guidewire Technologies, Inc.Guidewire Technologies, Inc. – FDA Inspection, Aug 16, 2012
Record Details
This FDA Inspection record concerns Guidewire Technologies, Inc., with an inspection on August 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guidewire Technologies, Inc.
- Inspection Date
- August 16, 2012
- Product Type
- Devices
View Company Profile
ID · b6e66120-1415-42d3-8f47-f68a4c1096bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794870
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.50(b)Supplier notification of changes
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 12, 2010 | 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 678089 - 2010-08-12
- FDA Inspection 644227 - 2010-01-22
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