483
PPD Development, L.P.PPD Development, L.P. – FDA 483, Apr 5, 2023
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.
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ID · 199ff82e-a934-4fac-9fec-faa0405a7238
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