FDA 483 - Med-Pharmex, Inc. - May 17, 2019

Med-Pharmex, Inc. received a Form 483 with 12 observations, many of which are repeat findings from a prior inspection. The inspection revealed significant deficiencies in aseptic processing, facility maintenance, cleaning and disinfection procedures, complaint handling, OOS investigations, visual inspection qualification, quality unit oversight, and laboratory controls, including data integrity issues with computer systems. These issues collectively indicate a systemic lack of control over sterile drug product manufacturing and quality assurance.