PAREXEL Early Phase Clinical Unit – FDA EIR, Oct 27, 2018

An FDA inspection of PAREXEL International LLC in Baltimore, MD, was conducted from October 15-17, 2018. This inspection focused on bioequivalence and Prescription Drug User Fee Act (PDUFA) compliance, adhering to regulatory guidelines for in vivo bioavailability/bioequivalence studies set by the Center for Drug Evaluation and Review (CDER). The facility conducts clinical trials under investigational new drug (IND) protocols for FDA-regulated products. The inspection covered various aspects, including informed consent, subject records, pharmacy operations, and biological sample handling. While overall processes appeared satisfactory and subjects met enrollment criteria, one key issue was identified: pharmacokinetic (PK) sampling deviations where biological samples were not processed within the specified timeframes. Management, specifically Ms. Erica Bahr, Senior Director of Quality Assurance, acknowledged these deviations and committed to implementing corrective actions. These actions may include adjustments to staffing and adding additional workstations to minimize future errors, with ongoing monitoring to ensure compliance. Crucially, no FDA Form 483, which lists objectionable conditions, was issued during this inspection, indicating that the noted deviations were addressed or considered minor with management's commitment to correction.