FDA 483 - Lions Eye Bank For Long Island - August 03, 2023

During an FDA inspection from July 26 to August 3, 2023, of Lions Eye Bank For Long Island, an ocular tissue bank located at 900 Franklin Ave, Valley Stream, NY, several observations were made. The inspection report was issued to Jason Tan, RN, Executive Director.

Observation 1 noted that a tracking system for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) was not maintained and followed. Specifically, there were no receipt and distribution records in the electronic inventory system for ocular tissue #(b) (6), (b) (7)(C) product code (b) (4), which was returned to the source eye bank on February 3, 2022. Additionally, the standard operating procedure SOP 7.550, "Acquisition of Tissue From Other Eye Banks," does not describe the process of entering tissues into the electronic system.

Observation 2 indicated that records were not maintained concurrently with the performance of each step. For example, ocular tissue #(b) (6), (b) (7)(C) product code (b) (4) was sent to a surgery center on October 1, 2021, at 05:53, returned at 10:30 according to one log, but 10:19 in the electronic system. Furthermore, a Tissue Return Form, required by the