Lymol Medical Corporation – FDA 483, Jul 29, 2021

Lymol Medical Corporation in Woburn, MA, a medical device manufacturer, received a Form FDA 483 with four repeat observations during an inspection from July 19-29, 2021. The inspection revealed significant issues with process validation, design control procedures, device history record maintenance, and supplier quality agreements. These findings indicate a lack of adequate quality system controls for medical device manufacturing.