FDA Inspection
Visionary Optics, LLCVisionary Optics, LLC – FDA Inspection, Oct 27, 2008
Record Details
This FDA Inspection record concerns Visionary Optics, LLC, with an inspection on October 27, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Visionary Optics, LLC
- Inspection Date
- October 27, 2008
- Product Type
- Devices
View Company Profile
ID · a72f8a5f-a564-4272-8681-6f00d8e79687
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 544753
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)General
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.70(a)(1)Process control instructions
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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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 |
| March 16, 2018 | 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 |
Other documents for Visionary Optics, LLC
- FDA Inspection 1239800 - 2024-05-17
- FDA Inspection 1044730 - 2018-03-16
- FDA Inspection 834001 - 2013-05-29
- FDA Inspection 813037 - 2013-01-08
- FDA Inspection 672379 - 2010-07-21
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