FDA 483 - Triumvirate Environmental, Inc. - March 18, 2019

An FDA inspection of Triumvirate Environmental, Inc. in Somerville, MA, a medical device manufacturer, revealed significant quality system deficiencies. Observations included a lack of documented personnel training, absence of written Medical Device Reporting (MDR) procedures, inadequate control of non-conforming products, and failure to include Unique Device Identifiers (UDI) in device history records or the GUDID database. These issues indicate a need for improved quality management practices at the facility.