FDA 483 - PPD Development, L.P.

An FDA inspection of PPD Development LLC in Middleton, WI, a Contract Research Organization (CRO), identified a data integrity issue related to the reporting of analytical results. The firm reported results for next generation impactor (NGI) data that were below the established limits of quantification (LOQs), indicating potential inaccuracies in their analytical methods or reporting practices. This observation suggests a moderate severity issue concerning data reliability in their in-vitro bioequivalence studies.