FDA Inspection 1321714 — Medartis Inc.
The FDA completed an inspection of Medartis Inc. on June 3, 2026 in Warsaw, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23209 | ISO 13485:2016 Clause 8.1 | Methods for monitoring, measurement, analysis, and improvement not determined |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |