FDA 483 - PPD Development, L.P. - April 05, 2023

An FDA inspection of PPD Development, L.P., a drug/device/biologics contract testing lab, was conducted from April 3-5, 2023. The inspection resulted in an FDA Form 483 observation, primarily citing that the company's procedures for corrective and preventive action (CAPA) were not adequately established. Specifically, the firm's SOP-17164, which governs Quality Risk Management, Root Cause Analysis, Trend Analysis, and CAPA, lacked a requirement for effectiveness checks for all corrective and preventive actions. For instance, CAPA 43630, initiated due to a failed container closure integrity test and a deficient testing method, was closed without documenting verification that the corrective actions taken were effective. While the FDA Form 483 lists observations and not a final determination, PPD Development, L.P. is expected to address these findings. The company must revise its CAPA procedures to ensure comprehensive effectiveness checks are routinely performed, thereby demonstrating adherence to regulatory requirements and maintaining the integrity of its quality system.