FDA 483 - CorneaGen LLC - September 24, 2021

Corneagen Inc. in Seattle, WA, was inspected by the FDA from September 23-24, 2021, regarding its human tissue operations. The inspection revealed a significant deficiency in record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically the failure to include the address of the donor-eligibility determination establishment in records for distributed corneal tissues.