FDA Inspection
Smith & Nephew, Inc.Smith & Nephew, Inc. – FDA Inspection, Dec 8, 2015
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc., with an inspection on December 8, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew, Inc.
- Inspection Date
- December 8, 2015
- Product Type
- Devices
View Company Profile
ID · 791e03db-6cce-48d8-a22c-c05906e33dd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960574
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| August 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smith & Nephew, Inc.
- FDA Inspection 1015137 - 2017-05-25
- FDA Inspection 740641 - 2011-08-15
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