FDA Inspection
EyeKon Medical, Inc.EyeKon Medical, Inc. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns EyeKon Medical, Inc., with an inspection on February 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8eb3c98-24c1-4465-b252-9ef6eda8161c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1042012
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EyeKon Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| November 28, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 3, 2008 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EyeKon Medical, Inc.
- FDA Inspection 1251720 - 2025-06-10
- FDA Inspection 809132 - 2012-11-28
- FDA Inspection 588902 - 2009-06-12
- FDA Inspection 540097 - 2008-10-03
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