483
LabCorp Indiana Inc.FDA 483 - LabCorp Indiana Inc. - July 13, 2021
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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.
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ID · a58661df-25bb-4c2b-ab1d-b6893677222b