483
Maria W. Greenwald, MDMaria W. Greenwald, MD – FDA 483, Nov 1, 2019
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.
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ID · 843d31a4-9389-4c39-add6-7124bbf77dea
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