PPD Development, L.P. – FDA EIR, Jul 16, 2021

PPD Development, LP, a control testing laboratory located in Middleton, WI, was subject to a comprehensive FDA surveillance inspection from July 12 to July 16, 2021. The inspection, conducted under Compliance Program 7345.848 for Biological Drug Products, evaluated the company's Quality System and Laboratory Control System, focusing on the testing of vaccine and biologics products. At the inspection's conclusion, a 3-item Form FDA-483, Inspectional Observations, was issued. The primary issues identified related to microbiological contamination control and laboratory procedures. Specifically, the inspection found that procedures designed to prevent microbiological contamination of test samples were not consistently followed or established. This included analysts failing to allow sanitizing solutions to dry on gloves and sleeves before working in ISO 5 Biosafety Cabinets (BSCs), and disruptive practices when introducing items into BSCs that compromised the protective air barrier. Furthermore, an analyst was observed not following specified aseptic techniques for handling test container lids during microbial limits testing. Another key observation was that media growth promotion procedures were not always executed according to established protocols, particularly concerning the required comparison criteria for qualifying media lots. In response to these findings, PPD Development, LP's management acknowledged the observations and stated their intention to submit a written response outlining their corrective actions within 15 business days.