FDA 483 - Becton Dickinson & Company - March 17, 2020

An FDA inspection of Becton Dickinson & Company in Franklin Lakes, NJ, from February 3 to March 17, 2020, revealed significant deficiencies in quality system procedures. The firm failed to adequately establish complaint handling procedures and submit Medical Device Reports (MDRs) within the required timeframe, both of which were repeat observations. Additionally, the inspection found that sampling methods for quality control were not adequately established or documented.