FDA 483 - Haematologic Technologies, LLC dba Prolytix - May 11, 2017

An FDA inspection of Haemtech Biopharma Services, a control testing laboratory in Essex Junction, VT, identified a significant deficiency in their quality control strategies. The firm failed to ensure that all original laboratory records, including electronic data, were subjected to a documented second-person review for accuracy. This observation highlights a concern regarding data integrity and proper reporting of test results for client drug samples.