Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank

Warning LetterClosed

Timothy M. Fischer President/Chief Executive Officer Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank 4745 Haven Point Blvd. Carmel , IN 46280 United States Tfischer@visionfirst.orgFEI 3000718320Issued Jun 10, 2024Division of Biological Products Operations II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3000718320.

Letter Details

Firm: Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank
Location: Timothy M. Fischer President/Chief Executive Officer Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank 4745 Haven Point Blvd. Carmel , IN 46280 United States Tfischer@visionfirst.org
FEI Number: 3000718320
Country: United States
Issue Date: June 10, 2024
Issuing Office: Division of Biological Products Operations II
Product Type: Biologics
Status: Closed
Closeout Letter: February 12, 2026

Summary

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank failed to comply with federal regulations governing human cells, tissues, and cellular products (HCT/Ps) during an FDA inspection conducted in January-February 2024. The company improperly determined five donors as eligible between January 2021 and January 2024 despite documented evidence of sepsis or other communicable disease risk factors that should have rendered them ineligible under 21 CFR 1271.75(a)(1), resulting in distribution of non-compliant ocular tissue products. These violations represented significant deviations from the regulatory requirements established under 21 CFR Part 1271 and the Public Health Service Act.

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank FDA Warning Letter, June 10, 2024