Guidewire Technologies, Inc. FDA Record
Guidewire Technologies, Inc. has 0 FDA recalls, 7 inspections, 3 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Guidewire Technologies, Inc., the most recent on Feb 26, 2010.
- Latest inspection
- Mar 28, 2025 · NAI
- Latest 510(k)
- Jul 31, 1990
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Guidewire Technologies, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Feb 26, 2010 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 28, 2025 | Salem, NH | Devices | No Action Indicated (NAI) | 1221806 |
| Mar 10, 2016 | Salem, NH | Devices | Voluntary Action Indicated (VAI) | 1221806 |
| Nov 19, 2014 | Salem, NH | Devices | No Action Indicated (NAI) | 1221806 |
| Aug 16, 2012 | Salem, NH | Devices | Voluntary Action Indicated (VAI) | 1221806 |
| Aug 12, 2010 | Salem, NH | Devices | Voluntary Action Indicated (VAI) | 1221806 |
| Jan 22, 2010 | Salem, NH | Devices | Official Action Indicated (OAI) | 1221806 |
| Nov 5, 2008 | Salem, NH | Devices | Voluntary Action Indicated (VAI) | 1221806 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Guidewire Technologies, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1221806 | Salem, NH | 7 | Mar 28, 2025 |
Guidewire Technologies, Inc. and the FDA: common questions
Has Guidewire Technologies, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Guidewire Technologies, Inc.. The most recent is dated Feb 26, 2010.
Has Guidewire Technologies, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Guidewire Technologies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Guidewire Technologies, Inc.?
The most recent FDA inspection on file ended Mar 28, 2025 at Salem, NH and was classified NAI. FDA has 7 inspections of Guidewire Technologies, Inc. on file, 1 of them classified OAI (official action indicated).
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