FDA Inspection 1222370 — Infinium Medical, Inc
The FDA completed an inspection of Infinium Medical, Inc on Nov 8, 2023 in Largo, FL. 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
- Nov 8, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |