# FDA 483 - WuXi Biologics Ireland Limited - December 16, 2025

Source: https://www.keypedia.com/records/483/wuxi-biologics-ireland-limited/46218d3f-8612-49e7-9718-ada2e1733c29

> FDA 483 for WuXi Biologics Ireland Limited on December 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi Biologics Ireland Limited
- Inspection Date: 2025-12-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: WuXi Biologics Ireland Limited, a drug substance manufacturer in Dundalk, Ireland, was cited for deficiencies across its manufacturing and laboratory operations. Observations included high defect rates in manufacturing equipment, inadequate laboratory controls leading to high invalid assay rates, poor documentation practices, and inappropriate Out of Specification (OOS) investigation procedures. These issues indicate a need for improved quality system oversight and corrective actions.

## Related Documents

- [483 - 2025-12-16](https://www.keypedia.com/records/483/wuxi-biologics-ireland-limited/87a27d78-c0ec-4cbb-81d3-623d878219af)

## Related Officers

- [Liqun Zhao](https://www.keypedia.com/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)
- [Dilip D. Devineni](https://www.keypedia.com/people/dilip-d-devineni/e03f6256-3a25-43ca-80f5-0f193dcc1fd8)

Company: https://www.keypedia.com/companies/wuxi-biologics-ireland-limited/e760930a-5cbb-4b0f-ac1a-8eb5be3948c1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4