FDA 483 - Esoterix Clinical Trials Services - June 27, 2018

An FDA inspection of Esoterix Inc. (Colorado Coagulation) in Englewood, CO, a bioanalytical testing laboratory, revealed significant issues with data integrity and recordkeeping for a clinical trial study. Observations included a failure to update reported results after an identified error in the Laboratory Information System and a lack of maintained correspondence necessary to reconstruct study events. Additionally, the firm lacked a formalized procedure for maintaining internal and external communications related to clinical trial work.