On Site Gas Systems Inc. – FDA 483, Mar 14, 2019

An FDA inspection of On Site Gas Systems Inc. in Newington, CT, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included the absence of unique device identifiers in device history records, a lack of risk analysis for their Portable Oxygen Generator Systems, and inadequate procedures for handling and evaluating complaints for Medical Device Report (MDR) reportability. These issues indicate a need for improved compliance with medical device regulations.