FDA Inspection 1256478 — Ikonisys Inc.
The FDA completed an inspection of Ikonisys Inc. on Dec 10, 2024 in New Haven, CT. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |