FDA 483 - Haematologic Technologies, LLC dba Prolytix - July 30, 2021

Haematologic Technologies, LLC, a contract testing laboratory in Essex Junction, VT, was cited for two observations during an FDA inspection. The firm failed to consistently follow its written procedures, specifically regarding Quality Assurance consultation during assay performance and the correct number of injections for a test method. Additionally, the firm did not adequately qualify test reagents for their intended purpose, leading to an invalid assay due to lot-to-lot variability.