FDA Inspection
Smith & Nephew Orthopaedics GmbHSmith & Nephew Orthopaedics GmbH – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns Smith & Nephew Orthopaedics GmbH, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 023d4417-dd73-4d64-a824-2188b3d03d20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Smith & Nephew Orthopaedics GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 22, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2010 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Smith & Nephew Orthopaedics GmbH
- FDA Inspection 1045278 - 2018-02-08
- FDA Inspection 1022654 - 2017-04-06
- FDA Inspection 928966 - 2015-05-07
- FDA Inspection 823996 - 2013-02-22
- FDA Inspection 681881 - 2010-07-22
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