FDA Inspection
Medacta International SAMedacta International SA – FDA Inspection, Nov 19, 2024
Record Details
This FDA Inspection record concerns Medacta International SA, with an inspection on November 19, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8c0d0098-aa7e-4f1a-97b9-04085102cc19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254603
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Medacta International SA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 30, 2018 | Not classified | Office of Inspections and Investigations | |
| June 19, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 5, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medacta International SA
- FDA Inspection 1256430 - 2024-11-19
- FDA Inspection 1141407 - 2018-08-30
- FDA Inspection 1019828 - 2017-06-19
- FDA Inspection 916801 - 2015-02-05
- FDA Inspection 651006 - 2010-01-28
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