FDA Inspection
Celonova Biosciences IncCelonova Biosciences Inc – FDA Inspection, May 19, 2014
Record Details
This FDA Inspection record concerns Celonova Biosciences Inc, with an inspection on May 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Celonova Biosciences Inc
- Inspection Date
- May 19, 2014
- Product Type
- Devices
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ID · 91ee057c-82b7-407e-8588-ac36a312229a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 881973
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Celonova Biosciences Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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