FDA Inspection
Celonova Biosciences Inc.Celonova Biosciences Inc. – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Celonova Biosciences Inc., with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Celonova Biosciences Inc.
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · 850dde80-d151-4e8e-993c-7282c7daedc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710546
- 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 820.198(a)Complaints
- 21 CFR 820.130Packaging
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.186QSR
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Other FDA inspections of Celonova Biosciences Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 13, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Celonova Biosciences Inc.
- FDA Inspection 982748 - 2016-08-11
- FDA Inspection 620007 - 2009-05-13
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