FDA Inspection
Visionary Contact Lens, Inc.Visionary Contact Lens, Inc. – FDA Inspection, Feb 17, 2017
Record Details
This FDA Inspection record concerns Visionary Contact Lens, Inc., with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7502cd26-ba4b-4f60-914a-67cd9bbbb992
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007175
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Visionary Contact Lens, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2025 | Not classified | Los Angeles District Office | |
| November 10, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 26, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Visionary Contact Lens, Inc.
- FDA Inspection 1263008 - 2025-02-06
- FDA Inspection 1156891 - 2021-11-10
- FDA Inspection 917208 - 2015-02-26
- FDA Inspection 665777 - 2010-06-09
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