FDA 483 - CorneaGen - Boston - June 09, 2023
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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.
ID · 83adf46e-9bd2-45b5-bdec-816b54f14c32