FDA Inspection
Talisman LimitedTalisman Limited – FDA Inspection, Nov 12, 2009
Record Details
This FDA Inspection record concerns Talisman Limited, with an inspection on November 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Talisman Limited
- Inspection Date
- November 12, 2009
- Product Type
- Devices
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ID · de80393b-f0ae-4405-8d21-f5ef5ca7f787
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626970
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Talisman Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Talisman Limited
- FDA Inspection 834079 - 2013-05-30
- FDA Inspection 699964 - 2010-11-18
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