CorneaGen LLCSeptember 24, 2021

FDA 483 - CorneaGen LLC - September 24, 2021

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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.

Company: CorneaGen LLC
Inspection Date: September 24, 2021
Product Type: Other
Office: Division of Human and Animal Food Operations - West VI
Person: Peter S. Kessler (Investigator)

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ID · aae3dd26-9856-4ba9-97cd-4cf35aeecf0f