FDA Inspection
Sanatmetal LTD.Sanatmetal LTD. – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns Sanatmetal LTD., with an inspection on September 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sanatmetal LTD.
- Inspection Date
- September 17, 2009
- Product Type
- Devices
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ID · d0af9493-b75a-4184-8f2f-d6fc24b5411d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 615769
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(d)Acceptance criteria not identified
- 21 CFR 820.30(f)Design verification acceptance criteria
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.90(a)Nonconforming product evaluation/investigation
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Other FDA inspections of Sanatmetal LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sanatmetal LTD.
- FDA Inspection 905850 - 2014-11-19
- FDA Inspection 799552 - 2012-09-13
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