FDA 483 - Isomedix Operations, Inc. - January 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.