483
Eugenia Girda, MDEugenia Girda, MD – FDA 483, Oct 18, 2022
Record Details
An FDA inspection of Eugenia Girda, MD, a clinical investigator in New Brunswick, NJ, revealed a significant issue regarding the conduct of a clinical study. The investigator failed to report multiple adverse experiences for several subjects to the sponsor, which is a violation of the signed FDA 1572 Investigator Agreement. This indicates a serious lapse in adherence to clinical trial protocols and regulatory requirements.
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ID · 945a56cc-b2ca-4e25-bd23-2e29869a6298
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