Liberty Engineering Inc – FDA 483, Dec 18, 2019

Liberty Engineering Inc, a medical device manufacturer in Newton, MA, was inspected by the FDA from December 12-18, 2019. The inspection revealed multiple significant deficiencies in their quality system, including inadequate equipment calibration, undocumented supplier evaluations, insufficient in-process testing documentation, lack of rework procedures, undocumented personnel training, and poorly maintained device history records. These issues indicate a failure to adhere to established quality system regulations for medical devices.