FDA EIR - Covance Laboratories, Inc. - September 02, 2011

An FDA routine Good Laboratory Practice (GLP) inspection of Covance Laboratories, Inc. in Vienna, VA, took place from August 30 to September 2, 2011. The inspection, conducted under the regulatory framework of 21 CFR Part 58, aimed at assessing compliance with GLP for human drugs. Its scope included a data audit of two specific non-clinical studies and a focused review of the facility's organization, personnel, quality assurance unit, and records. It was noted that Covance Laboratories was in the process of decommissioning its facility, having completed its last study on July 15, 2011, with buildings slated for demolition by 2012. Importantly, the inspection revealed no objectionable conditions, and consequently, no FDA Form 483, Inspectional Observations, was issued. No specific violations were identified, and therefore, no mandatory corrective actions were required from management beyond their general ongoing responsibility to comply with applicable regulations, particularly regarding the transfer of archived study records.