FDA 483 - Eye Bank For Sight Restoration Inc. - November 13, 2023

The FDA inspected Eye Bank For Sight Restoration Inc. in New York, NY, and found significant deficiencies primarily related to record-keeping, environmental controls, and sterilization process verification. Observations included failures to maintain concurrent and detailed records, inadequate control of environmental conditions to prevent contamination, and improper verification of supplies and reagents used to prevent communicable disease transmission. These issues indicate a lack of robust quality control and documentation practices.