FDA 483 - Pan Medical U.S. Corp - March 05, 2020

An FDA inspection of Pan Medical U.S. Corp in Largo, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate corrective and preventive action procedures, failure to implement effective Medical Device Reporting procedures resulting in late submissions, and insufficient validation of critical manufacturing processes. Additionally, environmental control procedures for their cleanroom were found to be lacking defined limits.