FDA Inspection
Guidewire Technologies, Inc.Guidewire Technologies, Inc. – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Guidewire Technologies, Inc., with an inspection on January 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guidewire Technologies, Inc.
- Inspection Date
- January 22, 2010
- Product Type
- Devices
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ID · 9bfc53dc-1d6c-4566-afcb-d054e7ffe97b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 644227
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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 |
| August 12, 2010 | VAI | 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 678089 - 2010-08-12
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