FDA Inspection
Tytan Medical Corp. ShanghaiTytan Medical Corp. Shanghai – FDA Inspection, Oct 28, 2010
Record Details
This FDA Inspection record concerns Tytan Medical Corp. Shanghai, with an inspection on October 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tytan Medical Corp. Shanghai
- Inspection Date
- October 28, 2010
- Product Type
- Devices
View Company Profile
ID · e966a55a-c952-41bf-9f35-729c5d513d0a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 701910
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Tytan Medical Corp. Shanghai
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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