483
Tech Group Europe LimitedFDA 483 - Tech Group Europe Limited - April 27, 2023
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An FDA inspection of Tech Group Europe Limited in Dublin, Ireland, from April 24-27, 2023, identified a significant quality system deficiency. The firm failed to adequately document corrective and preventive action activities, specifically regarding persistent foil leakage issues in FreeStyle Libre sensor containers. This indicates a lack of effective root cause analysis and implementation of corrective actions.
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ID · 46b2070e-c4fd-49c7-b17a-85459940c41b