483
Georgia Eye Bank, Inc.FDA 483 - Georgia Eye Bank, Inc. - May 24, 2019
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An FDA inspection of Georgia Eye Bank, Inc. in Atlanta, GA, identified a significant issue regarding process validation. The firm failed to establish and implement procedures to validate critical corneal processing methods, specifically for DMEK, DSEK, and LIKE procedures. This indicates a lack of control over processes that cannot be fully verified by inspection and tests.
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ID · 7cce4869-a420-4c24-a29b-86b4d75a83be