FDA 483 - Eurofins Pharma Bioanalytics Services US Inc. - August 21, 2015

An FDA inspection of Eurofins Pharma Bioanalytics Services US Inc. in St. Charles, MO, revealed significant deficiencies in their bioanalytical laboratory operations. The firm failed to follow established standard operating procedures for sample handling and deviation investigations, maintain adequate documentation, and adhere to study plans. Critical issues included the exclusion of data without defined criteria and the incomplete reporting of method validation data, indicating a lack of robust quality control and data integrity practices.