FDA 483 - Lawrence Ginsberg, M.D. - July 29, 2025

An FDA inspection of Lawrence Ginsberg, M.D. in Houston, TX, a clinical investigator, revealed that investigations were not conducted in accordance with the signed statement of investigator and investigational plan. The firm failed to ensure contemporaneous documentation of subject eligibility decisions and proper attribution of screening assessments. These findings indicate significant deficiencies in record-keeping and adherence to study protocols.