FDA Inspection
Fundus Photo, LLCFundus Photo, LLC – FDA Inspection, Dec 21, 2016
Record Details
This FDA Inspection record concerns Fundus Photo, LLC, with an inspection on December 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0a62c81f-4da6-4394-a457-d6fc96f41c56
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 995051
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Fundus Photo, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2025 | NAI | Kansas City District Office | Postmarket Assurance: Medical Devices |
| April 12, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 27, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fundus Photo, LLC
- FDA Inspection 1264899 - 2025-03-26
- FDA Inspection 1166861 - 2022-04-12
- FDA Inspection 709194 - 2011-01-27
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