FDA 483 - KLEB Inc - March 17, 2026

KLEB Inc in Louisville, KY, a human tissue establishment, was issued a Form 483 with two observations. The inspection revealed issues with maintaining documentation for equipment calibration, specifically for clean room temperature probes. Additionally, the firm failed to determine donor ineligibility despite medical records indicating risk factors for communicable diseases, leading to the distribution of tissues from an ineligible donor.