FDA EIR - The Rocky Mountain Lions Eye Bank - October 23, 2018

A comprehensive FDA inspection of The Rocky Mountain Lions Eye Bank (RMLEB) satellite facility in Aurora, CO, was conducted on October 23, 2018. The inspection, carried out under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), covered quality assurance, processing room qualification, and equipment qualification and maintenance. The primary finding was that the satellite facility, though registered for ocular tissue processing, has not been actively used for this purpose since December 2014. It currently functions as an emergency processing location and is primarily used for donor record storage, with all processing equipment and supplies requiring transport to the site if it were to become operational. Crucially, the inspection concluded without the issuance of an FDA-483 (Inspectional Observations), indicating no regulatory violations or deviations were identified. During the closing discussion, management was advised that registration might not be necessary if the facility is not actively used for tissue recovery or processing, though they expressed intent to maintain registration for potential future use. A concern from a previous inspection (August 2016) regarding emergency procedures was noted to have been successfully addressed through the implementation of a specific environmental control and maintenance procedure for the satellite facility. The inspection was classified favorably, with no formal actions required from the company.