FDA EIR - Intertek USA, Inc. - November 09, 2017

An FDA inspection of Intertek USA, Inc. (dba Intertek Pharmaceutical Services) took place from October 30 to November 09, 2017. This "premarket original" inspection, conducted under the Bioresearch Monitoring Compliance Program and focusing on Good Laboratory Practices (GLPs), was requested by the Center for Drug Evaluation and Research (CDER). The inspection identified significant issues, documented in a Form FDA 483 Inspectional Observations. Key findings included that the selected concentration of the confirmatory low positive control (LPC) was not representative of study samples. Additionally, several validation parameters for anti-drug antibody (ADA) assays were inadequately determined. This encompassed issues such as inappropriate LPC selection for selectivity assessment, lack of validated assay selectivity and specificity in confirmatory assays, insufficient evaluation of drug tolerance, and failure to assess the effect of hemolyzed plasma or long-term storage stability for ADA in human plasma. The company committed to providing a written response outlining their corrective actions to the Los Angeles District Office within 15 business days of the inspection's close.