FDA EIR - Spaulding Medical LLC - May 31, 2019

An FDA inspection of Spaulding Clinical Research, LLC, a contract research organization, was conducted from May 21-31, 2019. This inspection, carried out under Compliance Program 7348.003 for In Vivo Bioavailability/Bioequivalence Studies and referencing regulations 21 CFR 320.63 and 21 CFR 320.38, focused on two drug studies (a premarket original New Drug Application and a supplement). The FDA issued a two-item FDA-483, Inspectional Observations, detailing significant issues. The primary violation involved the failure to retain adequate reserve samples of test articles and reference standards for a bioequivalence study. Specifically, Spaulding Clinical Research did not set aside retention samples from three separate shipments for one study and failed to follow established retention procedures, resulting in inaccurate records, including lot number discrepancies for retained products in another study. The second major issue was improper informed consent documentation; an unapproved version of the informed consent form was used for screening 45 subjects in one of the reviewed studies. Management acknowledged these findings and stated their commitment to implementing comprehensive corrective actions to address the identified deficiencies.