FDA 483 - Dr. Peter Szmuk - April 17, 2015

Dr. Peter Szmuk, a Principal Investigator in Dallas, TX, was cited for significant deficiencies during an FDA inspection related to clinical investigations. The inspection revealed failures in obtaining legally effective informed consent, ensuring all research activity changes were IRB-approved, maintaining adequate case histories, and conducting the investigation in accordance with the approved protocol. These issues indicate a lack of proper oversight and adherence to regulatory requirements for human subject protection and data integrity.