FDA Inspection
Jardon Eye Prosthetics, Inc.Jardon Eye Prosthetics, Inc. – FDA Inspection, Mar 2, 2026
Record Details
This FDA Inspection record concerns Jardon Eye Prosthetics, Inc., with an inspection on March 2, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Jardon Eye Prosthetics, Inc.
- Inspection Date
- March 2, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 79578cf0-3de6-4fea-bae7-054e0ddf8afc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1305052
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
8- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 5.5.1Management responsibilities and authorities not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jardon Eye Prosthetics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 7, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 30, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Jardon Eye Prosthetics, Inc.
- FDA Inspection 1024335 - 2017-08-31
- FDA Inspection 858542 - 2013-12-12
- FDA Inspection 748664 - 2011-10-07
- FDA Inspection 666773 - 2010-06-16
- FDA Inspection 580924 - 2009-04-30
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