FDA 483 - CorneaGen - Boston - June 09, 2023

An FDA inspection of CorneaGen - Boston, a human tissue establishment, revealed significant deficiencies in environmental monitoring and reagent control. The firm failed to monitor environmental conditions during the production of in-house reagents used for cornea processing. Additionally, documentation for reagent verification lacked test results and certificates of analysis, and receipt records were missing critical information like manufacturer and expiration dates.