FDA Inspection
Genicon, Inc.Genicon, Inc. – FDA Inspection, Jan 17, 2020
Record Details
This FDA Inspection record concerns Genicon, Inc., with an inspection on January 17, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Genicon, Inc.
- Inspection Date
- January 17, 2020
- Product Type
- Devices
View Company Profile
ID · a21d65bc-f713-40dc-b86a-c87b4c7bb75b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115560
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
Showing 10 of 15 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genicon, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1029478 - 2017-10-20
- 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.