Covance Laboratories, Inc. – FDA 483, Nov 2, 2000

An FDA inspection of Covance Laboratories, Inc. in Vienna, VA, a non-clinical laboratory, revealed significant issues related to study conduct and data integrity. Observations included the failure to review clinical history records, leading to the inclusion of Hepatitis A positive animals in a study, and inaccuracies in the final report regarding animal testing. Additionally, the firm failed to include dosage formulation analyses in a final report and exhibited poor record-keeping for protocol amendments and equipment documentation.