Lions Eye Bank of Wisconsin, Inc. – FDA 483, Jul 6, 2026

An FDA inspection of Lions Eye Bank of Wisconsin, Inc. in Madison, WI, revealed a significant delay in reporting an adverse reaction. The firm failed to submit a required FDA Form 3500A within the mandated 15-day timeframe, submitting it 17 days late. This indicates a lapse in timely adverse event reporting procedures for an HCT/P Eye Bank.