FDA Inspection
Genesis Biosystems, IncFDA Inspection 1195256 - Genesis Biosystems, Inc - January 09, 2023
Record Details
This FDA Inspection record concerns Genesis Biosystems, Inc, with an inspection on January 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 56cafdb9-2cb5-48d7-b263-558789820d00
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1195256
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Genesis Biosystems, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Genesis Biosystems, Inc
- FDA Inspection 1028385 - 2017-08-31
- FDA Inspection 928343 - 2015-06-01
- FDA Inspection 908043 - 2014-12-16
- FDA Inspection 838279 - 2013-06-27
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