FDA Inspection
OriGen Biomedical, Inc.OriGen Biomedical, Inc. – FDA Inspection, Jul 5, 2018
Record Details
This FDA Inspection record concerns OriGen Biomedical, Inc., with an inspection on July 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fcae7e18-3d90-4a20-88bf-10fc03ac7b3f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1059095
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of OriGen Biomedical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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