KLEB IncMarch 17, 2026

FDA 483 - KLEB Inc - March 17, 2026

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Record Details

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.

Company: KLEB Inc
Inspection Date: March 17, 2026
Product Type: Other
Office: FDA District Office — Cincinnati, Ohio
Person: Jennifer L. Sheehan

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