FDA Inspection
Medartis Inc.Medartis Inc. – FDA Inspection, Jun 3, 2026
Record Details
This FDA Inspection record concerns Medartis Inc., with an inspection on June 3, 2026, issued by the Detroit District Office, covering medical devices & rad health.
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ID · cad4b72e-940b-4235-b023-2b801990a886
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1321714
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 8.1Methods for monitoring, measurement, analysis, and improvement not determined
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
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Other FDA inspections of Medartis Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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