FDA Inspection
Smith & Nephew, Inc.Smith & Nephew, Inc. – FDA Inspection, Aug 31, 2011
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc., with an inspection on August 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew, Inc.
- Inspection Date
- August 31, 2011
- Product Type
- Devices
View Company Profile
ID · ada4f439-bd7d-4cbc-a929-61cc75c8a4b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 743018
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| November 26, 2013 | OAI | 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 858923 - 2013-11-26
- FDA Inspection 610762 - 2009-09-04
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