FDA 483 - NeuroLogica Corporation - January 14, 2020

NeuroLogica Corporation in Danvers, MA, was cited for three observations related to regulatory reporting and record-keeping for lasers used in their CT Systems. The inspection revealed failures to submit required product reports and annual reports, as well as a lack of adequate test records for electronic product radiation safety. These issues indicate deficiencies in compliance with regulations concerning medical device reporting and safety documentation.