GUIDEWIRE TECHNOLOGIES, INC. FDA Inspection Record
GUIDEWIRE TECHNOLOGIES, INC. is an FDA-registered facility (FEI 1221806) located in SALEM, NH, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Mar 28, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (1 OAI, 4 VAI, 2 NAI)
- Last OAI inspection
- Jan 22, 2010
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 26, 2010
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 28, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 10, 2016 | Voluntary Action Indicated (VAI) | Management review - defined interval, sufficient frequency (21 CFR 820.20(c)) Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b)) Lack of Written MDR Procedures (21 CFR 803.17) |
| Nov 19, 2014 | No Action Indicated (NAI) | No citations listed |
| Aug 16, 2012 | Voluntary Action Indicated (VAI) | Supplier notification of changes (21 CFR 820.50(b)) |
| Aug 12, 2010 | Voluntary Action Indicated (VAI) | Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Jan 22, 2010 | Official Action Indicated (OAI) | Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) DMR device specifications (21 CFR 820.181(a)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) Quality Audit/Reaudit - conducted (21 CFR 820.22) and 6 more |
| Nov 5, 2008 | Voluntary Action Indicated (VAI) | Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
FDA record score
0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 10, 2016 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Aug 16, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Aug 12, 2010 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Feb 26, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jan 22, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Nov 5, 2008 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Guidewire Technologies, Inc.
- Location
- SALEM, NH (US)
- Source
- device