FDA 483 - NeuroLogica Corporation - August 27, 2024

NeuroLogica Corporation, a manufacturer of CT systems in Danvers, MA, was cited for two significant issues during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for malfunctions in their CT systems that led to patients needing rescans and additional radiation exposure. Additionally, it was noted as a repeat observation that the firm did not submit required reports for the IEC Class 1M laser incorporated into their CT systems.