# FDA 483 - Halo Medical Technologies - May 23, 2022

Source: https://www.globalkeysolutions.net/records/483/halo-medical-technologies/85550121-9875-4744-8015-1a41e72ced69

> FDA 483 for Halo Medical Technologies on May 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Halo Medical Technologies
- Inspection Date: 2022-05-23
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Halo Medical Technologies in Bethlehem, PA, a medical device manufacturer, was inspected by the FDA from May 18-23, 2022. The inspection revealed one significant observation concerning the firm's failure to develop and implement written Medical Device Reporting (MDR) procedures. This indicates a critical lapse in their system for evaluating medical device-related adverse events.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.globalkeysolutions.net/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.globalkeysolutions.net/companies/halo-medical-technologies/bd0c6525-9589-4c43-9ccb-5e45f0e1df08

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8