FDA 483 - Boston Analytical, Inc. - January 24, 2020

Boston Analytical, Inc., a control testing laboratory in Salem, NH, was cited for failing to follow written procedures for sampling and testing drug products. The microbiology laboratory repeatedly failed to adequately follow microbial enumeration test methods, as evidenced by numerous instances of positive growth on negative controls. These failures were not reported to clients, indicating a significant breakdown in quality control and data integrity.