FDA Inspection
Smith & Nephew, Inc.Smith & Nephew, Inc. – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns Smith & Nephew, Inc., with an inspection on August 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Bonnie E. Conley (Issuing Officer)
- Mary A. Millner
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ID · fd39576a-b8ba-4bf3-b687-8febeb19e56d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020184
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Smith & Nephew, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 2, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 11, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 17, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 27, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Smith & Nephew, Inc.
- FDA Inspection 1158635 - 2021-12-09
- FDA Inspection 1041637 - 2018-02-02
- FDA Inspection 1012033 - 2017-05-11
- FDA Inspection 984209 - 2016-08-17
- FDA Inspection 885233 - 2014-06-27
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