FDA Inspection 1256214 — Halo Dream, Inc ( Formerly Halo Innovations, Inc.)
The FDA completed an inspection of Halo Dream, Inc ( Formerly Halo Innovations, Inc.) on Dec 6, 2024 in New York, NY. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |