# FDA 483 - Halo Dream, Inc ( formerly Halo Innovations, Inc.) - November 19, 2021

Source: https://www.globalkeysolutions.net/records/483/halo-dream-inc-formerly-halo-innovations-inc/6dc0ac93-82e1-4348-989b-5057d0d8d4da

> FDA 483 for Halo Dream, Inc ( formerly Halo Innovations, Inc.) on November 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Halo Dream, Inc ( formerly Halo Innovations, Inc.)
- Inspection Date: 2021-11-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Halo Innovations, Inc. in New York, NY, revealed two significant issues. The firm failed to establish written procedures for electronic Medical Device Reporting (eMDR) and did not adequately document design validation results in their design history file. These observations indicate deficiencies in quality system procedures and documentation practices.

## Related Documents

- [483 - 2024-12-06](https://www.globalkeysolutions.net/records/483/halo-dream-inc-formerly-halo-innovations-inc/e5557acd-e2a9-4b35-b67b-0c69c887de8a)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/halo-dream-inc-formerly-halo-innovations-inc/33cb9b03-43c5-4ecc-b6f6-38233098f690

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961