FDA 483 - Keystone Bioanalytical, Inc. - June 28, 2019

An FDA inspection of Keystone Bioanalytical, Inc. in North Wales, PA, conducted from June 24-28, 2019, identified a significant issue regarding data integrity and quality control. The contract research organization failed to report all method validation data, specifically omitting results from LLOQ samples that, when included, demonstrated out-of-specification inter-batch precision. This indicates a failure to ensure the accuracy and reliability of their bioanalytical method validation processes.