FDA 483 - Beckman Research Institute, City of Hope - August 20, 2025

An FDA inspection of Beckman Research Institute, City of Hope, a control test laboratory in Duarte, CA, revealed significant deficiencies in laboratory controls and quality unit procedures. Observations included inadequate method validation for commercial products, insufficient scientific justification for reference standard qualification, and critical data integrity issues related to electronic data review, user authentication, and segregation of duties. The firm also lacked adequate procedures for documenting and investigating laboratory events, potentially compromising the validity of test results.