FDA 483 - Exact Medical Manufacturing, Inc. - March 11, 2021

Exact Medical Manufacturing, Inc. in Lancaster, NY, was inspected regarding its medical device manufacturing processes. The inspection revealed significant deficiencies in design controls, specifically concerning design validation and documentation of design input requirements for ultrasound transducer/probe covers. Additionally, the firm's corrective and preventive action procedures were found to be inadequate, a repeat observation from a previous inspection.