FDA 483 - PPD, Inc., part of Thermo Fisher Scientific - August 15, 2019

PPD, Inc. in Wilmington, NC was inspected by the FDA from August 12-15, 2019. The inspection revealed a significant failure to ensure investigations were conducted in accordance with the general investigational plan and protocols specified in the IND. This included not following internal data validation procedures, unlocking subject records without prior sponsor approval, and issues with managing subject dose adjustments, leading to protocol violations.