FDA Inspection
Visioncare Devices, Inc.Visioncare Devices, Inc. – FDA Inspection, Jun 26, 2013
Record Details
This FDA Inspection record concerns Visioncare Devices, Inc., with an inspection on June 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Visioncare Devices, Inc.
- Inspection Date
- June 26, 2013
- Product Type
- Devices
View Company Profile
ID · 4540bbdb-312a-4c7c-b941-3f02c147a43e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838960
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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