FDA 483 - LifeSignals Imaging, Inc. - March 11, 2021

An FDA inspection of LifeSignals Imaging, Inc. in New York, NY, a medical device manufacturer, revealed three significant issues. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking electronic MDR procedures for serious incidents. Additionally, records of changes did not adequately identify affected documents, and complaint files were not properly maintained, as design weaknesses were not identified as customer complaints.