Kabe Labortechnik GmbH

Warning LetterOpen

Andre Kolpe Managing Director Kabe Labortechnik GmbH Jagerhofstr. 17 Numbrecht 51588 North Rhine-Westphalia Germany (b)(6)@kabe-labortechnik.deFEI 3002807393Issued May 9, 2025Center for Devices and Radiological Health

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Violations8

Issue DateMay 9, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Kabe Labortechnik GmbH
Location: Andre Kolpe Managing Director Kabe Labortechnik GmbH Jagerhofstr. 17 Numbrecht 51588 North Rhine-Westphalia Germany (b)(6)@kabe-labortechnik.de
FEI Number: 3002807393
Country: Germany
Issue Date: May 09, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Kabe Labortechnik GmbH FDA Warning Letter, May 9, 2025