Maria W. Greenwald, MDNovember 1, 2019

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

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Record Details

An FDA inspection of Maria Greenwald, MD, a clinical investigator in Palm Desert, CA, revealed a significant deficiency in record-keeping practices. The firm failed to prepare or maintain adequate and accurate case histories, specifically regarding the availability of required chest x-rays and discrepancies in subject randomization records. This indicates a severity related to data integrity and protocol adherence in clinical investigations.

Company: Maria W. Greenwald, MD
Inspection Date: November 1, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Mendoza O. Wallace
Diane C. Van Leeuwen (issuing_officer)

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ID · 843d31a4-9389-4c39-add6-7124bbf77dea