483
PPD Development, L.P.FDA 483 - PPD Development, L.P. - April 05, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 199ff82e-a934-4fac-9fec-faa0405a7238