FDA EIR - Greiner Bio-One GmbH - October 25, 2018

An FDA "For Cause" inspection of Greiner Bio-One GmbH, a medical device manufacturer based in Kremsmuenster, Austria, was conducted from October 22-25, 2018. The inspection, carried out under CP7382.845 for Medical Device Manufacturers, focused on the firm's Class 2 Vacuette K2 EDTA blood collection tubes, which are regulated by the FDA under the FD&C Act. The inspection identified significant deficiencies, leading to the issuance of an FDA Form 483, Inspectional Observations. Key issues included inadequate design controls, particularly concerning software validation. Procedures for radiation sterilization were found to be deficient, specifically the failure to identify a representative product for a product family, violating ISO Standard 11137-2 and 21 CFR 820.75(a). Furthermore, the firm's corrective and preventive action (CAPA) system was inadequately established, with shortcomings in identifying root causes, ensuring effectiveness of corrective actions, and proper documentation. Concerns were also raised regarding the lack of rationale for 510(k) submissions for design and material changes, which could impact device safety and effectiveness. Greiner Bio-One GmbH management acknowledged the observations and committed to submitting a written response outlining corrective actions within 15 business days. The FDA emphasized that these deficiencies could lead to regulatory actions such as a Warning Letter or import detention if not adequately addressed. The firm subsequently submitted a response with proposed corrective actions, which will require review during a future inspection to confirm effective implementation.