FDA Inspection 1120620 — 410 Medical, Inc.
The FDA completed an inspection of 410 Medical, Inc. on Mar 12, 2020 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |