Covance Laboratories, Inc. – FDA EIR, Jul 27, 2000

An FDA inspection of Covance Laboratories, Inc.'s Vienna, VA facility was conducted from July 12 to 27, 2000. This comprehensive surveillance and directed data audit, overseen by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), focused on compliance with Good Laboratory Practice (GLP) regulations.

The inspection revealed several significant deficiencies. Covance failed to handle and analyze chemistry specimens according to written procedures, often holding them for extended periods without clear guidelines. Documentation for sample tracking records was not properly maintained. A critical issue was the failure to archive study records as required, with one study's data found outside the designated archives. The firm also did not adhere to written procedures for audit trails, as their system failed to capture new data values when changes were made, and validation testing was insufficient. Furthermore, conflicting timelines were found in sample collection and processing records, and a Final Report for a study was incomplete, lacking details on animal watering methods and identification systems.

In response, Covance Laboratories, Inc. committed to corrective actions. They revised the Standard Operating Procedure (SOP) for specimen handling, located the missing sample tracking records, and archived the previously unarchived study data during the inspection. For the audit trail deficiency, the company initially proposed to amend the SOP, but subsequent review indicated a remaining inconsistency. Discrepancies in sample collection times were addressed by documenting a "Study Protocol Official Communication" form. The company also promised to amend the incomplete Final Report. A formal response to the FDA 483 was submitted on August 25, 2000, addressing all identified observations.