FDA 483 - Boston Scientific Corporation - September 22, 2017

The FDA inspection of Boston Scientific Corporation in Saint Paul, MN, revealed significant non-compliance with Good Laboratory Practice (GLP) regulations during nonclinical laboratory studies, particularly study 13-137G. Key issues included deviations from study protocols, inaccuracies in final reports, inadequate quality assurance oversight, and failures in data integrity, personnel qualifications, and record archiving. These observations highlight systemic deficiencies in the firm's preclinical device evaluation processes.