FDA Inspection
Smith & Nephew, Inc.Smith & Nephew, Inc. – FDA Inspection, Aug 15, 2011
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc., with an inspection on August 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew, Inc.
- Inspection Date
- August 15, 2011
- Product Type
- Devices
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ID · 222e3ce1-d872-459f-90fc-18018f5755df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740641
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of Smith & Nephew, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smith & Nephew, Inc.
- FDA Inspection 1015137 - 2017-05-25
- FDA Inspection 960574 - 2015-12-08
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