483
PPD Development, L.P.FDA 483 - PPD Development, L.P. - September 25, 2025
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
PPD Development, L.P. in Middleton, WI, a contract laboratory, was issued a Form 483 with three observations. The inspection revealed deficiencies in employee training for drug product processing, inadequate controls over temperature-controlled equipment, and a lack of written procedures for quality control unit responsibilities. These issues highlight concerns regarding good manufacturing practices and potential risks to product quality.
Open in Dashboard
ID · e2239a11-ea51-47a5-b646-89e4ea475acb