LifeSignals Imaging, Inc. – FDA 483, Mar 11, 2021

LifeSignals Imaging, Inc., a medical device manufacturer in New York, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed deficiencies in maintaining written Medical Device Reporting procedures, inadequate record-keeping for changes to documents, and failures in properly maintaining complaint files. These issues indicate a need for improved quality system controls.