FDA Inspection
Smith & Nephew Inc.Smith & Nephew Inc. – FDA Inspection, Mar 26, 2015
Record Details
This FDA Inspection record concerns Smith & Nephew Inc., with an inspection on March 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smith & Nephew Inc.
- Inspection Date
- March 26, 2015
- Product Type
- Devices
View Company Profile
ID · 358cc24b-160a-4dab-9742-f5bbf7a0698a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 920985
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| August 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smith & Nephew Inc.
- FDA Inspection 1155885 - 2021-10-26
- FDA Inspection 993232 - 2016-11-09
- FDA Inspection 606855 - 2009-08-06
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