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Kabe Labortechnik GmbH, a German manufacturer of blood collection tubes including the SAFE-TFILL Capillary Blood Collection Systems, failed to comply with FDA's Quality System Regulation (QSR) requirements for medical devices. During a January 2025 inspection, investigators identified that the firm had not adequately validated its manufacturing process for these blood collection systems, which are filled onsite with anticoagulant coating, in violation of 21 CFR 820.75(a) requirements for process validation. The company's response to initial FDA 483 observations, submitted in January 2025, was found to be insufficient to address the identified deficiencies in manufacturing controls and procedures.