FDA WARNING_LETTER - Lone Star Lions Eye Bank - July 25, 2011

The FDA conducted an inspection of Lone Star Lions Eye Bank, Inc. from July 20-25, 2011, identifying significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A Form FDA-483 was issued.

Key violations include: 1. **Failure to retain records (21 CFR 1271.55(d)(4)):** The firm failed to retain donor eligibility records for at least 10 years, discarding medical records and other source documents once eligibility was determined and recorded. This was a repeat observation from a 2009 inspection. The firm's August 31, 2011 response was deemed inadequate. 2. **Failure to establish proper manufacturing procedures (21 CFR 1271.270(b)):** * SOP D1.000 "Donor Eligibility Criteria - Policy" incorrectly allowed discarding medical record copies after relevant information was recorded. * SOP M1.000 "Eye Bank Records" stated a 10-year retention but then permitted purging "non-required" medical charts and copies once eligibility was determined and tissues distributed.

The FDA emphasized that this is not an exhaustive list and the firm must comply with all federal regulations. Failure to take prompt corrective action could