FDA 483 - Element Materials Technology Boston - Acton Inc. - August 01, 2025

An FDA inspection of Element Materials Technology Boston - Acton, Inc. revealed significant deficiencies in its quality control unit and equipment logging practices. The firm failed to properly investigate environmental monitoring excursions and out-of-specification results, and its raw material control system was inadequate. Additionally, critical equipment logs for endotoxin testing lacked essential batch processing details, indicating a need for improved record-keeping and quality oversight.