PPD Development, L.P. – FDA EIR, Apr 26, 2019

An FDA inspection was conducted at PPD Bioanalytical Lab in Middleton, WI, from April 22-26, 2019. This BIMO program inspection focused on evaluating method validation and sample analysis activities for drug applications involving Tezacaftor and Ivacaftor. Notably, the inspection concluded without the issuance of a Form FDA 483, indicating that no formal objectionable conditions or regulatory violations were identified. However, the report documented several instances of freezer temperature excursions, including temporary deviations caused by probe calibration and sample relocation after maintenance. A significant event occurred on August 20, 2018, when a severe weather-related power outage caused all freezers to lose power for approximately 12 hours. During this incident, samples stored in two -20°C freezers thawed, though samples in -70°C freezers maintained their integrity. The company had pre-established long-term stability data for Tezacaftor and Ivacaftor and their metabolites in human plasma at both -70°C and -20°C for over 700 days, and benchtop stability for over 24 hours. The inspection confirmed overall compliance with regard to personnel training, instrument calibration, data security, sample handling, and adherence to Standard Operating Procedures. No specific regulatory violations or corrective actions were formally required as a result of this inspection.