FDA 483 - Luis Zepeda, M.D. - February 15, 2022

An FDA inspection of Accurate Clinical Management Llc in Houston, TX, revealed critical deficiencies in their clinical investigation practices. The firm failed to maintain adequate and accurate case histories, with issues such as unverified source data, missing subject identification, and non-contemporaneous or inconsistent entries. Additionally, investigational drug disposition records were found to be inadequate, exhibiting non-contemporaneous entries, altered data, and missing receiving/shipping documentation.