Isomedix Operations, Inc. – FDA 483, Jan 27, 2026
An FDA inspection of Isomedix Operations, Inc. in Libertyville, IL, identified three significant observations related to the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to maintain records of HCT/P storage temperatures, lacked established procedures for HCT/P storage, and did not document preventative maintenance for equipment used in HCT/P storage. These deficiencies indicate a failure to meet current good tissue practice (CGTP) requirements.
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