FDA Inspection
Chitogen, Inc.Chitogen, Inc. – FDA Inspection, May 18, 2011
Record Details
This FDA Inspection record concerns Chitogen, Inc., with an inspection on May 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chitogen, Inc.
- Inspection Date
- May 18, 2011
- Product Type
- Devices
View Company Profile
ID · 31e1734e-7c70-49ab-a578-a38d556aa3cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725056
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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 |
| April 12, 2010 | 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 658411 - 2010-04-12
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