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

Source: https://www.keypedia.com/records/483/lions-eye-bank-of-wisconsin-inc/cbdd0d61-efff-47ae-a7a8-6c37d7fd0ce3

> FDA 483 for Lions Eye Bank of Wisconsin, Inc. on July 06, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lions Eye Bank of Wisconsin, Inc.
- Inspection Date: 2026-07-06
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Kenneth L. Smalls](https://www.keypedia.com/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.keypedia.com/companies/lions-eye-bank-of-wisconsin-inc/a2395773-c7cf-4d6e-9bd7-ccc3ee520392

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d