FDA Inspection
Chitogen, Inc.Chitogen, Inc. – FDA Inspection, Apr 12, 2010
Record Details
This FDA Inspection record concerns Chitogen, Inc., with an inspection on April 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chitogen, Inc.
- Inspection Date
- April 12, 2010
- Product Type
- Devices
View Company Profile
ID · 78514ef3-036d-4d27-bd7a-9bf006a95ea5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658411
- 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 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chitogen, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Chitogen, Inc.
- FDA Inspection 1233462 - 2024-03-19
- FDA Inspection 984816 - 2016-02-03
- FDA Inspection 812627 - 2012-12-19
- FDA Inspection 725056 - 2011-05-18
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