FDA 483 - ICON Laboratory Services, Inc. - April 25, 2024

An FDA inspection conducted from April 8 to April 25, 2024, at a biopharmaceutical analytical facility in Whitesboro, NY, resulted in a Form FDA 483 outlining significant observations. The primary issue identified was the firm's failure to adhere to its Standard Operating Procedure (SOP) BC04, titled "LC_MS Analysis of Study Samples Within ICON Bioanalytical Laboratories," particularly concerning the processing and reporting of re-analysis results for study "NN", Job Number "G4". Specifically, the firm incorrectly reported original values instead of the mean for 224 of 290 reanalyzed samples where the percentage difference was less than 20%. Furthermore, for 13 samples, the original value was reported despite the percentage difference exceeding 20%, contrary to the SOP's mandate of providing no reportable result. The inspection also noted that 283 out of 2,051 subject samples underwent single repeat analysis, deviating from the SOP's requirement for duplicate analysis when sufficient sample volume was available. These observations signify a breakdown in quality system adherence and data integrity, necessitating a prompt and comprehensive response from the firm detailing corrective actions to ensure regulatory compliance and prevent recurrence.