FDA EIR - Rocky Mountain Lions Eye Bank - April 26, 2018

An FDA inspection of Rocky Mountain Lions Eye Bank in Aurora, CO, occurred from April 20-26, 2018. This comprehensive review, conducted under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), examined all operational facets, including quality assurance, tissue processing, donor eligibility, and recordkeeping. Although no FDA-483 was issued during this inspection, three notable issues were identified and discussed with the firm's management. These involved inaccuracies in electronic donor records regarding cornea recovery times, insufficient documentation on cleaning records for specific equipment, and instances of illegible information on donor medical history questionnaires. The inspection also referenced a previous review from May 2015, which resulted in an FDA-483 for two deficiencies: failure to retain third-party records used for donor eligibility determinations and not reporting deviations from established good tissue practices. That prior inspection was classified as "Voluntary Action Indicated," prompting the firm to address those observations. The recent discussions from the 2018 inspection underscore the expectation for Rocky Mountain Lions Eye Bank to address the newly identified discrepancies in their record-keeping and documentation to uphold regulatory compliance.