FDA 483 - Labcorp Early Development Laboratories, Inc. - August 17, 2018

From August 13-17, 2018, Covance Laboratories Inc. in Madison, WI, underwent an FDA inspection under the Good Laboratory Practice (GLP) Bioresearch Monitoring (BIMO) framework. The inspection revealed two primary observations. Firstly, the company failed to adequately test, calibrate, or standardize equipment, specifically histopathology tissue processors. Issues included a lack of validation for reagent change processes and neglected preventative maintenance for certain processors, contravening internal Standard Operating Procedures (SOPs). Secondly, the facility demonstrated inadequate storage practices for feed and bedding. A warehouse used for these critical items continued operation despite a vendor assessment that did not recommend approval, and without a documented improvement plan as provisionally agreed upon. Additionally, the firm did not adhere to its own SOP for assessing and approving animal food/bedding vendors. Covance is required to respond to these observations by outlining objections or detailing implemented or planned corrective actions to ensure compliance with regulatory standards.