FDA 483 - CorneaGen, Inc. - July 29, 2022

Corneagen, Inc. in South San Francisco, CA, a human tissue establishment, was cited for two significant observations during an FDA inspection. The firm failed to validate processing steps for its ocular allograft products, raising concerns about contamination and the spread of communicable diseases. Additionally, the environmental monitoring program for ocular tissue processing was deemed inadequate, as monitoring was not performed at each processing event.