FDA 483 - Haematologic Technologies, LLC dba Prolytix - June 25, 2019

Haematologic Technologies Inc., a contract testing laboratory in Essex Junction, VT, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate or absent written procedures, failure to investigate out-of-specification results, lack of electronic data management protocols, and insufficient quality oversight for contract services. These issues indicate significant gaps in the firm's quality system and data integrity practices.