FDA Inspection
Smith & Nephew, Inc. Advanced Surgical Devices DivisionSmith & Nephew, Inc. Advanced Surgical Devices Division – FDA Inspection, Jun 11, 2013
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc. Advanced Surgical Devices Division, with an inspection on June 11, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 11, 2013
- Product Type
- Devices
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ID · 90162397-f040-4398-9683-a0b5cc66706a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834988
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Smith & Nephew, Inc. Advanced Surgical Devices Division
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smith & Nephew, Inc. Advanced Surgical Devices Division
- FDA Inspection 1031107 - 2017-08-21
- FDA Inspection 601510 - 2009-07-31
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