FDA Inspection
Smith & Nephew, Inc.Smith & Nephew, Inc. – FDA Inspection, Nov 26, 2013
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc., with an inspection on November 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew, Inc.
- Inspection Date
- November 26, 2013
- Product Type
- Devices
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ID · 3e04d3e2-68f8-4f4d-b510-bcf42aa146d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 858923
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Smith & Nephew, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 31, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Smith & Nephew, Inc.
- FDA Inspection 907062 - 2015-01-13
- FDA Inspection 743018 - 2011-08-31
- FDA Inspection 610762 - 2009-09-04
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