FDA 483 - Maria W. Greenwald, MD - November 01, 2019

During an inspection conducted from October 28 to November 1, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Maria Greenwald, MD, a clinical investigator, detailing significant observations related to record-keeping and protocol adherence. These findings, issued under the Federal Food, Drug and Cosmetic Act, indicate a failure to adequately prepare and maintain accurate case histories and pertinent data for a clinical investigation. Specifically, inspectors observed that required screening chest x-rays, as outlined in Section 6.1.2 of the study protocol, were unavailable for review for several subjects. Furthermore, a critical discrepancy was identified in subject randomization records: one subject's investigational product assignment in the Investigational Product Administration Log contradicted the information recorded in the electronic Case Report Form. These observations highlight concerns regarding data integrity and compliance with study protocols. While the FDA 483 document serves as a notification of objectionable conditions, it is not a final determination of compliance. Maria Greenwald, MD is now expected to formally address these observations by implementing comprehensive corrective actions. These actions should focus on ensuring complete and accurate documentation, resolving all data inconsistencies, and reinforcing adherence to established protocols and regulatory guidelines to prevent recurrence and maintain the reliability of clinical trial data.