FDA Inspection
Genesis Biosystems, IncFDA Inspection 908043 - Genesis Biosystems, Inc - December 16, 2014
Record Details
This FDA Inspection record concerns Genesis Biosystems, Inc, with an inspection on December 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Genesis Biosystems, Inc
- Inspection Date
- December 16, 2014
- Product Type
- Devices
View Company Profile
ID · e855a5cc-38ed-48c4-a42b-5a365dc9b681
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908043
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genesis Biosystems, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 31, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Genesis Biosystems, Inc
- FDA Inspection 1195256 - 2023-01-09
- FDA Inspection 1028385 - 2017-08-31
- FDA Inspection 928343 - 2015-06-01
- FDA Inspection 838279 - 2013-06-27
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.