FDA EIR - Covance Laboratories Inc. - June 06, 2014

An FDA inspection of Covance Laboratories, Inc. in Chantilly, VA, was conducted from June 3-6, 2014. The inspection was a high-priority pre-approval data validation audit focused on bioequivalence and pharmacokinetics/pharmacodynamics studies for human drugs, operating under the regulatory framework of 21 CFR 320.29(a) and BioAnalytical Method Validation guidance. The inspection reviewed various records, including sample management, equipment calibration, and personnel training, for specific bioanalytical projects.

Crucially, the inspection concluded without the issuance of an FDA Form 483, signifying that no objectionable conditions requiring formal corrective action were identified. Discussions with management included minor observations, such as instances of incorrect outlier flagging in data tables (which did not affect study results), and questions regarding matrix effects in calibrator and quality control sample preparation. Some internal procedural deviations were noted in study correspondence, such as minor centrifugation time discrepancies and data saving issues due to network problems, but these were deemed by the firm's Principal Investigator to have no impact on study integrity. No formal violations were cited, and no required actions or voluntary corrections were mandated as a result of this inspection.