FDA EIR - Covance Laboratories Inc. - January 20, 2016

Covance Laboratories Inc., located in Greenfield, IN, underwent a comprehensive FDA surveillance inspection from January 19-20, 2016. The inspection focused on the company's Good Manufacturing Practices (GMP) operations as a contract testing laboratory. Its services include biopotency/bioidentity testing, protein characterization, ELISA/Immunoassay, and particulate analysis for clinical drug products and drug substances. The regulatory framework for this inspection included FDA compliance programs 7356.002 for Drug Manufacturing Inspections and 7356.002F for Active Pharmaceutical Ingredients. The review encompassed various aspects of the quality and laboratory systems, such as change controls, out-of-specification investigations, validation activities, data integrity, sample handling, and equipment maintenance. Notably, the inspection concluded with no inspectional observations or objectionable conditions identified by the FDA. Consequently, no regulatory actions were required from the agency, and no samples were collected during the inspection.