Hubly Inc. – FDA 483, May 22, 2026

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.