FDA 483 - Boston Scientific Corporation - November 18, 2021

An FDA inspection of Boston Scientific Corporation's nonclinical laboratory in Saint Paul, MN, revealed multiple deficiencies in adherence to Good Laboratory Practice (GLP) regulations. Observations included inadequate protocols for tissue evaluation during necropsy, failure to accurately record experimental data, and improper retention of wet tissue specimens. Additionally, the firm was cited for unlabeled reagents and a quality assurance unit that did not ensure proper specimen identification, impacting the integrity and reliability of safety studies for implanted medical devices.