FDA 483 - New Mexico Lions Sight Conservation Foundation, Inc. - February 28, 2024

The FDA conducted an inspection of New Mexico Lions Sight Conservation Foundation, Inc., a human tissue establishment, between February 23 and February 28, 2024. The inspection resulted in two main observations concerning donor eligibility and procedural controls.

The first critical issue identified was that the firm determined donors eligible even when medical records documented risk factors or clinical evidence of communicable disease agents, specifically sepsis. Examples provided illustrate instances where ocular tissues were recovered and shipped from donors explicitly diagnosed with sepsis, contrary to appropriate screening practices.

The second observation pointed to deficiencies in the company's written procedures, including its "Donor Eligibility Determination," "Sepsis Algorithm," and "Donor Screening Criteria Guide." These procedures were found to be inadequately designed, failing to ensure that deceased donors with a sepsis diagnosis are consistently deemed ineligible. Moreover, the procedures did not require a comprehensive review of all available medical records for sepsis diagnosis or clinical evidence throughout the entire hospital stay preceding the donor's death, limiting the review to only a partial period.

These findings indicate a need for the company to enhance its adherence to regulatory requirements for human tissue establishments, particularly in thoroughly assessing donor medical history for communicable disease risks. The firm is expected to implement corrective actions to address these observations and ensure full regulatory compliance.