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

Source: https://www.keypedia.com/records/483/tech-group-europe-limited/46b2070e-c4fd-49c7-b17a-85459940c41b

> FDA 483 for Tech Group Europe Limited on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tech Group Europe Limited
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/tech-group-europe-limited/fdd1a66b-0aed-4328-8d34-ef04491b34ec

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1