FDA Inspection
Xstrahl LimitedXstrahl Limited – FDA Inspection, Sep 22, 2011
Record Details
This FDA Inspection record concerns Xstrahl Limited, with an inspection on September 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Xstrahl Limited
- Inspection Date
- September 22, 2011
- Product Type
- Devices
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ID · a7195193-5e68-44cd-a391-ba74a8076775
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 750003
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Xstrahl Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Xstrahl Limited
- FDA Inspection 750735 - 2011-09-22
- FDA Inspection 553042 - 2008-12-04
- FDA Inspection 553041 - 2008-12-03
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