FDA Inspection
Smith & Nephew Inc.Smith & Nephew Inc. – FDA Inspection, Aug 6, 2009
Record Details
This FDA Inspection record concerns Smith & Nephew Inc., with an inspection on August 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew Inc.
- Inspection Date
- August 6, 2009
- Product Type
- Devices
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ID · d0058292-fab6-484a-a365-07fc2b0884fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Smith & Nephew Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Smith & Nephew Inc.
- FDA Inspection 1155885 - 2021-10-26
- FDA Inspection 993232 - 2016-11-09
- FDA Inspection 920985 - 2015-03-26
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