FDA Inspection
Nova Biomedical CorporationNova Biomedical Corporation – FDA Inspection, Apr 4, 2017
Record Details
This FDA Inspection record concerns Nova Biomedical Corporation, with an inspection on April 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9d49e80-0ea3-4490-bbb6-53ef4af40c81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008368
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Nova Biomedical Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nova Biomedical Corporation
- FDA Inspection 865722 - 2014-02-12
- FDA Inspection 762854 - 2012-01-13
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