FDA 483 - PPD Development, L.P. - July 12, 2021

An FDA inspection of PPD Development, LP's Control Testing Laboratory in Middleton, WI, revealed significant deficiencies in microbiological control. Observations included analysts not following aseptic techniques, inadequate media growth promotion procedures, and unvalidated environmental and personnel monitoring methods. These issues raise concerns about the integrity of microbial testing and potential contamination of test samples.