FDA EIR - PPD Development, L.P. - June 20, 2014

An FDA inspection of PPD Development, LLC, in Middleton, WI, was conducted from June 16-20, 2014. This high-priority, pre-approval data validation inspection, under Compliance Program 7348.001, In Vivo Bioequivalence, covered bioanalytical portions of clinical trials supporting NDA and ANDA submissions. The inspection reviewed the firm's analytical testing practices, personnel qualifications, and procedures, including method validations and analytical study data.

Despite the thorough review, no significant objectionable conditions or practices were observed, and consequently, no FDA-483, Inspectional Observations, was issued. However, two procedural items were raised as discussion points with management. First, there was a lack of clear documentation for an investigation into a pump calibration failure, as required by firm procedure LE 024, although subsequent evidence confirmed no detrimental impact on data. Second, the initial pre-dilution of certain subject samples for analysis was not explicitly noted in the PPD method or reported in the result tables, despite prior email communication with the sponsor. PPD management acknowledged these observations and committed to addressing them to ensure procedural compliance.