FDA 483 - PPD Development, L.P. - September 25, 2025

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.