FDA Inspection
Chitogen, Inc.Chitogen, Inc. – FDA Inspection, Feb 3, 2016
Record Details
This FDA Inspection record concerns Chitogen, Inc., with an inspection on February 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chitogen, Inc.
- Inspection Date
- February 3, 2016
- Product Type
- Devices
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ID · 2430cc8f-c944-45c7-8c44-2511f481f815
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984816
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Chitogen, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2024 | 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 |
| 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 812627 - 2012-12-19
- FDA Inspection 725056 - 2011-05-18
- FDA Inspection 658411 - 2010-04-12
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