FDA EIR - LabCorp Indiana Inc. - July 13, 2021

An FDA priority inspection of LabCorp Indiana Inc., located in South Bend, IN, was conducted from July 7 to July 13, 2021. This comprehensive surveillance inspection, guided by CPGM 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), found the firm operating as a contract testing laboratory for a hematopoietic stem cell manufacturer. The inspection focused on the firm's quality program, standard operating procedures, training, equipment maintenance, and sterility testing deviations. A significant observation, documented on an FDA Form 483, highlighted that the firm's quality program failed to investigate, document, or report deviations related to sterility testing protocols, specifically three instances of analyzer malfunctions in February and October 2020, and June 2021. These malfunctions affected numerous HCT/P sterility tests and were not properly addressed in accordance with 21 CFR 1271.160(b)(6). Additionally, the inspection revealed a lack of consistent quality oversight, with the quality program not performing reviews for over five months, nor leading quality meetings since February 2021. There was also a failure to track and trend deviations for approximately a year, with no Quality Management Reports generated since the second quarter of 2020. Management indicated that LabCorp Indiana Inc. or its parent company would likely respond to the FDA's observations within the 15-day timeframe and stated intentions to review and improve their practices.