FDA 483 - Covance Laboratories, Inc. - July 12, 2000

During an inspection, Covance Laboratories, Inc. in Vienna, VA, was cited for multiple failures in their nonclinical laboratory operations. Observations included inadequate handling and analysis of chemistry specimens, failure to maintain sample handling documentation, and unarchived study records. Additionally, the firm failed to follow written procedures for computer system audit trails, had conflicting blood sample records, and produced incomplete final study reports.