Covance Laboratories, Inc. – FDA EIR, Feb 8, 2019

An FDA surveillance inspection was conducted at Covance Laboratories Inc. in Chantilly, VA, from January 28 to February 8, 2019. This inspection, performed by the Office of Study Integrity and Surveillance (OSIS) under the analytical BIMO program (Compliance Program 7348.004), focused on bioanalytical facilities, records, method validation, and sample analysis relevant to a biologics license application. Earlier inspections in December 2016 and April/May 2017 had revealed significant deficiencies. The 2016 inspection cited issues such as improper selection of anti-drug antibody (ADA) screening cut points, failure to demonstrate ADA detection in the presence of study drug, inadequate selectivity and precision for diluted pharmacokinetic (PK) samples, insufficient stability data for PK studies, and improper data handling. The 2017 inspection identified non-adherence to acceptance criteria for ADA confirmatory assays. Notably, the 2019 inspection found no objectionable conditions. The FDA verified that Covance Laboratories Inc. had successfully implemented voluntary corrective actions to address all previously identified issues. As a result, no new Form FDA 483 was issued, indicating the company's improved compliance with regulatory expectations for its bioanalytical operations.