FDA 483 - LabCorp Indiana Inc. - July 13, 2021

An FDA inspection of LabCorp Indiana Inc. in South Bend, IN, revealed a critical deficiency in their quality program. The firm failed to properly investigate, document, and report multiple malfunctions of an analyzer used for HCT/P sterility testing, impacting donor eligibility determinations. This indicates a serious lapse in adherence to core Current Good Tissue Practice (CTGP) requirements for deviation management.