FDA 483 - Essex Industries, Inc. - December 16, 2022

Essex Industries, Inc. in Affton, MO, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to submit a Medical Device Report (MDR) within the required timeframe after becoming aware of a Therapeutic Liquid Oxygen System malfunction. Additionally, the company did not adequately review and evaluate customer complaints and returned Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) devices.