FDA Inspection 1151122 — Medartis Inc.
The FDA completed an inspection of Medartis Inc. on September 3, 2021 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
- September 3, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |