HCTP Violations at Indiana Lions Eye Bank

A 1/22-2/1 FDA inspection at the Indiana Lions Eye Bank, doing business as VisionFirst Indiana Lions Eye Bank in Carmel, IN, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 6/10 Warning Letter says the “items of concern” were:

• failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable agents or diseases for which screening is required; and
• failure to ensure procedures comply with the donor eligibility requirements in regulations.

FDA tells the eye bank to promptly correct the violations and to respond with a list of specific actions it has taken or will take to correct the violations and prevent them from recurring, with documentation of the actions and a schedule for completing the corrections.