FDA EIR - LabCorp CLS - February 15, 2019

An FDA bioanalytical Bioresearch Monitoring (BIMO) program inspection of Covance Bioanalytical Services, LLC. in Indianapolis, IN, was conducted from February 11 to February 15, 2019. The inspection, led by Srinivas R. Chennamaneni, Ph.D., from the Office of Study Integrity and Surveillance (OSIS) under Compliance Program 7348.004, focused on the company's method validation and sample analysis activities for various drug applications. The review encompassed critical areas including personnel training, facility operations, sample storage, instrument calibration, data security, and standard operating procedures. A detailed audit of bioanalytical data covered method validation components (e.g., precision, accuracy, stability, matrix effects) and sample analysis procedures (e.g., sample receipt, processing, calibration curves, quality controls, chromatograms, and audit trails). Crucially, at the conclusion of the five-day inspection, no objectionable conditions were observed by the FDA investigator. Consequently, a Form FDA 483, which lists inspectional observations of concern, was not issued to Covance Bioanalytical Services, LLC. This indicates that the facility was found to be in compliance with the relevant regulatory frameworks governing bioanalytical services for clinical and non-clinical laboratory studies. Therefore, no specific required actions were mandated as a result of this inspection.