FDA 483 - 3D Imaging Drug Design and Development - January 31, 2024

An FDA inspection of 3D Imaging Drug Design and Development, a PET Drug Producer in Little Rock, AR, revealed significant deficiencies in their written procedures. The firm lacked adequate procedures for the receipt, evaluation, and reporting of post-marketing adverse drug experiences, as well as for the correct retention timeframe of drug product complaint records. These issues indicate a failure to establish proper controls for drug safety reporting and complaint handling.