FDA Inspection
Genicon, Inc.Genicon, Inc. – FDA Inspection, Nov 7, 2008
Record Details
This FDA Inspection record concerns Genicon, Inc., with an inspection on November 7, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Genicon, Inc.
- Inspection Date
- November 7, 2008
- Product Type
- Devices
View Company Profile
ID · 6b878b20-cd7a-4693-9364-eadb5b14127e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 548132
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(g)Design validation - user needs and intended uses
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 |
| 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 |
Other documents for Genicon, Inc.
- FDA Inspection 1115560 - 2020-01-17
- FDA Inspection 1029478 - 2017-10-20
- FDA Inspection 923674 - 2015-04-21
- FDA Inspection 775196 - 2012-03-29
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