FDA Inspection
MicroVision, Inc.MicroVision, Inc. – FDA Inspection, Sep 29, 2009
Record Details
This FDA Inspection record concerns MicroVision, Inc., with an inspection on September 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MicroVision, Inc.
- Inspection Date
- September 29, 2009
- Product Type
- Devices
View Company Profile
ID · 2ecf4472-356c-4eb9-b2e8-c70e2ba7f7d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615770
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.70(c)Environmental control system-documentation/review inspection
- 21 CFR 820.25(a)Sufficient personnel
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MicroVision, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 3, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MicroVision, Inc.
- FDA Inspection 1206173 - 2023-05-25
- FDA Inspection 1105419 - 2019-10-03
- FDA Inspection 1036680 - 2017-12-06
- FDA Inspection 913515 - 2015-01-22
- FDA Inspection 812394 - 2012-12-20
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