483
LifeSignals Imaging, Inc.FDA 483 - LifeSignals Imaging, Inc. - March 11, 2021
Record Details
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.
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ID · ad678a8d-9d73-4d0f-a3d4-6213d27fe475