# Hubly Inc. – FDA 483, May 22, 2026

Source: https://www.keypedia.com/records/483/hubly-inc/2d0805f5-17e2-4bd9-867c-ac98c94eabd5

> FDA 483 for Hubly Inc. on May 22, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubly Inc.
- Inspection Date: 2026-05-22
- Product Type: device
- Office Name: Chicago District Office
- Summary: Hubly Inc., a specification developer for the Hubly Cranial Electric Access Drill, was cited for significant quality system deficiencies during an FDA inspection in Lisle, IL. Observations included inadequate monitoring of a contracted QMS supplier, leading to failures in complaint handling, risk management, and supplier qualification. Most critically, the firm failed to submit a Medical Device Report within 30 days for an incident where the drill malfunctioned, causing a serious brain injury to a patient.

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)

Company: https://www.keypedia.com/companies/hubly-inc/b245d1e8-9cf0-4a67-b21d-25dba406ddfc

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669