FDA EIR - The Rocky Mountain Lions Eye Bank - August 30, 2016

A routine FDA inspection of the Rocky Mountain Lions Eye Bank (RMLEB) Annex in Aurora, CO, was conducted from August 29-30, 2016. This was the first inspection of this emergency processing location, which handles the processing and labeling of corneas and sclera. The inspection was carried out under Compliance Program 7341.002, focusing on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The review encompassed new annex procedures, processing room qualification, tissue processing validation, distribution, and equipment management.

Significantly, no official violations (FDA-483) were issued during the inspection. However, key discussion items were raised for RMLEB's management. These included the need for the company to develop a current and comprehensive emergency plan for the annex and to determine and inform the FDA’s Denver District Office of its long-term strategy for the facility. The inspection aimed to ensure the facility maintains compliant operations and has clear future plans for its annex activities. Previous regulatory action in 2004 regarding record-keeping was noted, with subsequent corrections implemented by the firm.