FDA 483 - Michael A. Hassman, DO - June 20, 2023

An FDA inspection of Michael A. Hassman, DO in Berlin, NJ, a clinical investigator, revealed a significant deficiency in record retention. The firm failed to retain investigational records, specifically source data for subject assessments, for the required two-year period following drug marketing application approval. This indicates a critical lapse in data integrity for clinical study protocol (b) (4).