483
CorneaGen - BostonCorneaGen - Boston – FDA 483, Jun 9, 2023
Record Details
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.
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ID · 83adf46e-9bd2-45b5-bdec-816b54f14c32
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