FDA EIR - Rocky Mountain Lions Eye Bank - August 21, 2015

An FDA inspection of Rocky Mountain Lions Eye Bank (RMLEB) in Aurora, Colorado, was conducted from August 17-21, 2015. This routine, comprehensive inspection, performed under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), covered various operations including donor eligibility, tissue processing, facilities, and quality control. At the conclusion of the inspection, an FDA-483 was issued, detailing two main observations. First, RMLEB failed to retain all records used to determine donor eligibility from third-party sources, such as hospital or coroner records. These documents were destroyed approximately six months after donor eligibility was determined and quality reviews were complete, a repeat observation from a previous inspection. Second, the firm did not report deviations from core current Good Tissue Practice (cGTP) requirements to the FDA. Specifically, it was found that an expired work surface cleaning agent was used during the recovery of tissues from two donors, which should have been reported as a deviation. Edmund P. Jacobs Jr., Executive Director, committed to providing a written response to the identified objectionable conditions and discussion items to the District Director within 15 business days. The inspection report also noted that FDA sanctions were described to the firm.