FDA Inspection
Guidewire Technologies, Inc.Guidewire Technologies, Inc. – FDA Inspection, Mar 10, 2016
Record Details
This FDA Inspection record concerns Guidewire Technologies, Inc., with an inspection on March 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guidewire Technologies, Inc.
- Inspection Date
- March 10, 2016
- Product Type
- Devices
View Company Profile
ID · 2db0e975-66ca-4ba1-8f73-f85de8a961d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963384
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 803.17Lack of Written MDR Procedures
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 | |
| November 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2012 | VAI | 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 903156 - 2014-11-19
- FDA Inspection 794870 - 2012-08-16
- FDA Inspection 678089 - 2010-08-12
- FDA Inspection 644227 - 2010-01-22
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