FDA EIR - Huntingdon Life Sciences, Inc. - August 14, 2020

An FDA surveillance inspection of Covance Laboratories, Inc., located in Somerset, NJ, was conducted from August 6 to August 14, 2020. This inspection focused on the non-clinical laboratory testing facility, guided by Good Laboratory Practice (GLP) regulations (CP 7348.808). Unlike a previous inspection in 2017, which identified significant issues such as failure to issue final reports for studies, non-compliance with protocols, and inadequate documentation of deviations, the current inspection concluded without the issuance of a Form FDA-483 (Inspectional Observations). The comprehensive review covered areas including the master schedule, personnel, quality assurance, equipment, and study execution. During a general discussion with management, the firm was reminded of two minor operational points: ensuring proper disposal of test articles and preventing test articles from entering the control processing room. While a written response was not formally required, Covance Laboratories voluntarily committed to providing one. The FDA's recommendation for this inspection is "No Action Indicated" (NAI), pending final classification by CDER, signifying a satisfactory compliance status at the time of the inspection regarding the regulatory framework for non-clinical laboratories.