FDA EIR - Donor Network of Arizona - June 06, 2022

An FDA inspection of Donor Network of Arizona, a human tissue facility in Tempe, AZ, was conducted from June 1-6, 2022. The inspection, part of the Office of Biological Product Operations' workplan and guided by Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), focused on the company's operations for recovering and processing various human tissues and ocular tissues. While no formal FDA Form 483 was issued, two non-reportable observations were discussed with management. First, during environmental monitoring, the firm's procedures for handling action limit detections were not consistently followed. On seven occasions, despite action limits being met, sampling was not performed immediately after decontamination, instead deferring to the next scheduled monitoring. Second, during pre/post operation contamination monitoring, two instances of post-operation bioburden growth were detected (fungus, Micrococcus luteus) without documented evidence of the required review and determination of these events as per their standard operating procedures. Donor Network of Arizona's management committed to implementing corrections for these identified issues.