FDA 483 - Tech Group Europe Limited - April 27, 2023

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.