FDA Inspection
OriGen Biomedical, Inc.OriGen Biomedical, Inc. – FDA Inspection, Apr 26, 2013
Record Details
This FDA Inspection record concerns OriGen Biomedical, Inc., with an inspection on April 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OriGen Biomedical, Inc.
- Inspection Date
- April 26, 2013
- Product Type
- Devices
View Company Profile
ID · c701929f-9f68-435e-8797-d3832f2d8d66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828408
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| July 5, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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