FDA Inspection
Visionary Optics, LLCVisionary Optics, LLC – FDA Inspection, Mar 16, 2018
Record Details
This FDA Inspection record concerns Visionary Optics, LLC, with an inspection on March 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5d0243e-4df6-45c7-bff0-6104d8a7f2e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044730
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Visionary Optics, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 29, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2008 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Visionary Optics, LLC
- FDA Inspection 1239800 - 2024-05-17
- FDA Inspection 834001 - 2013-05-29
- FDA Inspection 813037 - 2013-01-08
- FDA Inspection 672379 - 2010-07-21
- FDA Inspection 544753 - 2008-10-27
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