PPD Development, L.P. – FDA EIR, May 18, 2018

An FDA inspection of PPD Development LLC in Middleton, WI, was conducted from May 14 to May 18, 2018, as an unannounced In Vitro Bioequivalence Analytical Site audit under compliance program CP 7348.004. The inspection resulted in the issuance of an FDA Form 483, Inspectional Observations. The primary observation noted was the firm's use of an expired reference standard, specifically for studies conducted after December 2015, when the standard had expired. This issue was identified across multiple method validation studies for various analytes. Additionally, observations during the close-out meeting highlighted deficiencies in bioanalytical data, including the use of an inadequate number of Quality Control (QC) concentrations for precision and accuracy assessments, and insufficient calibration curve points in certain studies, which deviated from bioanalytical method validation guidance. PPD Development LLC management acknowledged the observations, stating they would respond in writing to the FDA 483, providing evidence of the reference material's stability for the duration of the studies. They also informed the FDA that their analytical method validation Standard Operating Procedures had been updated to align with current bioanalytical method validation guidance requirements. The firm was advised to submit a written response within 15 business days.