FDA EIR - Paul Harmatz, M.D. - November 05, 2020

The FDA conducted an inspection of Paul Harmatz, M.D., a Clinical Investigator located in Oakland, CA, from October 28 to November 5, 2020. The inspection lasted four days and concluded without the issuance of an FDA Form 483, "Inspectional Observations," meaning no formal regulatory violations were identified. However, the inspector discussed four key areas needing attention to ensure compliance with good clinical practice standards and FDA regulations for clinical trials. These included: the delayed updating of financial disclosure information; an observed lack of prompt resolution for action items identified during previous monitoring visits; the omission of two adverse events from the data listing for study BMN 111-205; and missing information regarding concomitant medications in the source documents. Although no formal deficiencies were cited requiring mandatory corrective actions, these discussion points highlight areas where improvements are recommended to enhance the overall quality and compliance of clinical trial conduct. The report noted that no samples were collected and no voluntary corrections were undertaken directly in response to this specific inspection.