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

An FDA inspection of PPD Development, L.P., a drug/device/biologics contract testing lab in Middleton, WI, revealed a significant deficiency in their quality system. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequate. Specifically, their CAPA SOP did not require effectiveness checks for all corrective and preventive actions, as demonstrated by a CAPA related to failed container closure integrity testing.