FDA Inspection
Genicon, Inc.Genicon, Inc. – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Genicon, Inc., with an inspection on October 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 5f7c1671-5e70-450c-a294-2ba380010786
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029478
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genicon, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Genicon, Inc.
- FDA Inspection 1115560 - 2020-01-17
- FDA Inspection 923674 - 2015-04-21
- FDA Inspection 775196 - 2012-03-29
- FDA Inspection 548132 - 2008-11-07
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.