George Kwiecinski

George Kwiecinski is a researcher at New York University whose work examines FDA inspection, enforcement, and public-record data as signals of pharmaceutical quality and supply risk. His current research pipeline includes a longitudinal map of drug-related Form FDA 483 observations to PDA technical categories, a transparent site-based risk calculation for inspection prioritization, and a study of the prevalence of artificial intelligence in FDA government correspondence. His peer-reviewed research has analyzed FDA warning letters and the relationship between GMP inspection coverage and U.S. pharmaceutical imports. He has presented at ISPE, PDA, ASQ, INTERPHEX, MARSQA, and the BARDA BioMaP Consortium.