PPD Development, L.P. – FDA EIR, Jun 20, 2014

An FDA inspection of PPD Development, LLC in Middleton, WI, was conducted from June 16 to June 20, 2014. This high-priority inspection, performed under Compliance Program 7348.001 for In Vivo Bioequivalence, focused on validating bioanalytical data for pre-approval New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). The scope included reviewing method validations and analytical study data for specific clinical trials. Significantly, the inspection concluded without the issuance of an FDA-483, indicating no significant objectionable conditions or practices were formally observed. However, two items were identified and verbally discussed with PPD management. First, documentation for an investigation into a failed calibration of an HPLC pump (P-119) was incomplete, not adhering to the firm’s procedure (LE 024). While PPD later provided evidence of no detrimental effect on data, the initial lack of documented investigation was noted. Second, for subject sample analyses in study (b)(4), initial pre-dilution of samples was performed but not explicitly mentioned in the PPD method or reported in the results tables. Management acknowledged these points and committed to implementing corrections, reinforcing adherence to internal procedures and comprehensive data reporting.