Integris Bioservices LLC – FDA EIR, Jun 24, 2016

From June 20 to June 24, 2016, KCAS, LLC, a contract research organization based in Shawnee, KS, underwent an FDA pre-approval data inspection by the Center for Drug Evaluation and Research (CDER). The inspection focused on bioanalytical operations, method validation, facilities, equipment, and study records for two bioequivalence (BE) studies submitted to the FDA for drug product approval. The regulatory framework primarily concerns the integrity and reliability of data supporting New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). The main violation, detailed in a one-item Form FDA 483, highlighted the company's failure to investigate a critical discrepancy during method validation. Specifically, the same lot of blank urine exhibited substantially varying concentrations (up to 300% difference) of a key analyte across original and amended validation experiments over a five-month period. This lack of investigation raised concerns about potential contamination or insufficient processing, directly impacting the accuracy and reliability of the bioanalytical method. As a required action, KCAS management, led by CEO John D. Bucksath, acknowledged the observation and agreed to submit a formal written response to the FDA 483 within 15 business days, detailing their corrective actions and preventive measures to address the identified issues. This ensures adherence to robust data integrity practices for future submissions.