FDA Inspection
Jardon Eye Prosthetics, Inc.Jardon Eye Prosthetics, Inc. – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Jardon Eye Prosthetics, Inc., with an inspection on August 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Aycock (Issuing Officer)
View Company Profile
ID · 672d76bb-feea-44bc-a94d-a3c7a7a28de4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024335
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jardon Eye Prosthetics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2026 | NAI | Detroit District Office | Postmarket Assurance: Medical 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 1305052 - 2026-03-02
- FDA Inspection 858542 - 2013-12-12
- FDA Inspection 748664 - 2011-10-07
- FDA Inspection 666773 - 2010-06-16
- FDA Inspection 580924 - 2009-04-30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.