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 3000215345.
Violations0
Issue DateJun 20, 2024
Product TypeBiologics
StatusOpen
Letter Details
Firm
New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank
Location
United States
FEI Number
3000215345
Country
United States
Issue Date
June 20, 2024
Issuing Office
Division of Biological Products Operations II
Product Type
Biologics
Status
Open
Summary
Based on limited metadata without access to the full warning letter, this FDA warning involves New Mexico Lions Eye Bank, a biologics manufacturer involved in eye tissue banking and conservation. The specific violations cannot be determined as the subject line is unavailable, though the warning likely pertains to manufacturing, processing, or quality control practices for human tissue products regulated as biologics. The warning was issued by the FDA in June 2024, indicating regulatory concerns with the company's operations that required formal corrective action notice.
New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank FDA Warning Letter, June 20, 2024