FDA Inspection
Diopsys, Inc.Diopsys, Inc. – FDA Inspection, Aug 11, 2011
Record Details
This FDA Inspection record concerns Diopsys, Inc., with an inspection on August 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diopsys, Inc.
- Inspection Date
- August 11, 2011
- Product Type
- Devices
View Company Profile
ID · a2580df7-19cb-45e6-8457-63f90a107b5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 744141
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.181(a)DMR device specifications
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Other FDA inspections of Diopsys, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Diopsys, Inc.
- FDA Inspection 947353 - 2015-11-02
- FDA Inspection 651054 - 2010-03-01
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