FDA EIR - New Mexico Lions Sight Conservation Foundation, Inc. - February 28, 2020

An FDA inspection of the New Mexico Lions Eye Bank in Albuquerque, NM, took place from February 25 to February 28, 2020. This routine inspection, conducted as part of the Office of Biological Products Operations (OBPO) workplan, adhered to the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCTPs) under the Public Health Service Act. The scope covered critical areas including donor eligibility determination, tissue recovery, cornea examination, labeling, and shipping processes. Additionally, the inspection reviewed screening protocols for Zika and Corona viruses, Standard Operating Procedures, temperature logs for storage units, and equipment preventive maintenance and calibration records. At the conclusion of the inspection, no significant deficiencies were noted, and a Form FDA 483, which formally cites objectionable conditions, was not issued to the New Mexico Lions Eye Bank. However, two discussion items were brought to management's attention. These involved an eye bank technician not fully adhering to the firm’s surgical scrub and gowning requirements (specifically, the donning of a second pair of sterile gloves) and placing a personal bag too close to a sterile field during a cornea recovery. Management was responsive and confirmed that these issues were addressed with the technician immediately. No formal regulatory actions were required, reflecting a generally compliant operation.