FDA Inspection 1157096 — Halo Dream, Inc ( Formerly Halo Innovations, Inc.)
The FDA completed an inspection of Halo Dream, Inc ( Formerly Halo Innovations, Inc.) on Nov 19, 2021 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |