FDA EIR - Covance Laboratories, Inc. - January 11, 2001

An FDA inspection of COVANCE LABORATORIES, INC. in Vienna, VA, was conducted from January 8-11, 2001, as a directed Pre-Approval Data Validation under C.P. 7348.001. The inspection identified significant issues documented on an FDA Form 483. Key observations included incomplete validation of assay methods, specifically the lack of in-house evaluation for long-term and refrigerated sample stability. The company also failed to consistently adhere to established protocol assay acceptance criteria, allowing deviations based on individual discretion. During one assay run, incorrect Quality Controls were inadvertently used, leading to questionable results. Furthermore, daily maintenance for an analyzer was not documented on several sample analysis dates. Discussions with management revealed additional concerns such as insufficient documentation of subject sample storage duration and the absence of a formal system for archiving all client correspondence, including requests for reassays. In response, Covance committed to providing a written response to the FDA 483, revising their Standard Operating Procedures to eliminate discretionary override of acceptance criteria, improving documentation for all assay steps, and ensuring more rigorous stability assessments in future validations. The firm also agreed to review and potentially remove questionable data from the final report and ensure all equipment usage is properly logged.