FDA 483 - Element Materials Technology Boston - Acton Inc. - May 04, 2026

Element Materials Technology Boston - Acton Inc., a contract testing laboratory in Acton, MA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleanroom re-certification after HVAC maintenance, environmental monitoring program discrepancies, poor facility maintenance, and insufficient investigations into out-of-specification results. These issues indicate a lack of control over critical sterility testing processes and facility upkeep.