FDA 483 - Foresight Imaging, LLC - December 20, 2022

Foresight Imaging, LLC, a medical device manufacturer in Chelmsford, MA, received a Form FDA 483 with two observations. The firm failed to adequately establish procedures for receiving and evaluating complaints, specifically regarding Medical Device Reporting (MDR) evaluations, which was noted as a repeat observation. Additionally, the design history file for their "TIMS MVP" device was not adequately maintained.