FDA 483 - Richard W. Foltin, Ph.D. - March 17, 2023

This FDA Form 483 was issued to Richard W. Foltin, Ph.D., a Sponsor-Investigator in New York, NY, following an inspection from February 28 to March 17, 2023. The inspection revealed significant non-compliance with clinical investigation regulations. Observations included initiating clinical studies requiring an Investigational New Drug (IND) application before the IND was in effect, and failing to obtain required FDA-1572 investigator statements prior to investigators participating in studies.