FDA WARNING_LETTER - Tissue Bank International/The National Eye Bank Center - June 20, 2012

The FDA conducted an inspection of Tissue Banks International, National Eye Bank Center (TBI/NEBC) from June 18-20, 2012, revealing significant deviations from Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations (21 CFR Part 1271). A FORM FDA 483 was issued, detailing three primary violations. First, the firm failed to validate and approve a cornea processing procedure used since 2006, with validation only initiated in May 2012, violating 21 CFR 1271.230(a). Second, TBI/NEBC failed to monitor environmental conditions in HCT/P processing areas during November 2011 and April 2012, contrary to 21 CFR 1271.195(c). Third, the firm did not document and maintain records for equipment maintenance, cleaning, sanitizing, and calibration as required by 21 CFR 1271.200(e), specifically lacking documentation for repeating failed sterilization runs and missing biological indicator test results on numerous occasions. The FDA acknowledged the firm's July 5, 2012, response but deemed it inadequate, particularly regarding environmental testing and documentation of repeated invalid tests. The letter also noted positive pre and post-processing cultures. TBI/NEBC is required to provide a written response within fifteen working days detailing corrective actions, including documentation, the final validation report, and actions taken for positive culture results, to prevent recurrence of these serious quality system and compliance issues.