FDA 483 - Eversight Illinois - June 18, 2024

During an FDA inspection conducted from June 12-18, 2024, Eversight Illinois, a processor of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), received an FDA Form 483 detailing significant observations. The inspection revealed deficiencies in adhering to Current Good Tissue Practice (CGTP) requirements, particularly concerning environmental monitoring and deviation investigations. The primary issues centered on the firm's failure to adequately investigate environmental monitoring excursions. In one instance, in June 2022, several processing rooms yielded "Too Numerous To Count" positive environmental cultures. Despite this, the firm's deviation investigation lacked documented corrective actions, root cause analysis, and effectiveness checks. Critically, these rooms continued to be used for processing and distributing surgical cornea for over two weeks following the positive results. Similarly, in November 2023, another environmental monitoring breach with 115 CFU growth in a processing room was not investigated, with the firm relying on an undocumented procedure of re-cleaning and re-testing rather than determining the source of contamination. These observations highlight a systemic problem where Eversight Illinois did not consistently follow its own standard operating procedures for investigating contamination sources and implementing appropriate corrective and preventive actions. The FDA 483 serves as a formal communication of these objectionable conditions and practices, requiring the firm to promptly address the findings by developing and implementing robust corrective actions to ensure compliance with regulatory standards and prevent recurrence.