PPD Development, L.P. – FDA EIR, Feb 13, 2014

A four-day pre-approval inspection by the FDA was conducted at PPD Development, LLC in Middleton, WI, from February 10-13, 2014. The inspection focused on the bioanalytical portion of a clinical trial supporting an NDA, under the regulatory framework of Compliance Program 7348.001 for In Vivo Bioequivalence. No FDA-483 Inspectional Observations were issued, indicating no significant objectionable conditions were found. However, six items were discussed with management for improvement. Key observations included deficiencies in documentation and procedural clarity. Specifically, ten out of thirty-nine reviewed preventative maintenance and calibration records were past due without adequate documented justification, contrary to internal procedures. General record-keeping for sample tracking needed improvement, including clearer documentation for "spawn" samples and the storage conditions of samples during unanticipated delays. The electronic Master Tracking Log also displayed an incorrect time zone, differing from the live system. Furthermore, the run acceptance criteria for a specific analytical method required clarification. Management acknowledged these points, promising corrections for the overdue maintenance records and discussing potential process enhancements like retaining "out of service" tags. The discussions aimed to enhance the firm's documentation and operational practices.