# FDA 483 - Lonza AG - April 04, 2025

Source: https://www.keypedia.com/records/483/lonza-ag/258011de-5647-45fe-8dbf-b3aeb72657c2

> FDA 483 for Lonza AG on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza AG
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Lonza AG in Visp, Switzerland, revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. Operators were observed covering sterile openings and blocking first air during aseptic assembly and stopper addition operations. These findings indicate a failure to establish and follow adequate controls for sterile manufacturing.

## Related Documents

- [483 - 2025-04-04](https://www.keypedia.com/records/483/lonza-ag/49d1c9a6-62e9-4d01-a2a3-bb792f53a7b4)

## Related Officers

- [Melissa D. Ray](https://www.keypedia.com/people/melissa-d-ray/d3edab82-132c-4a8f-997a-19d610a4f03a)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Hyung-yul Lee](https://www.keypedia.com/people/hyung-yul-lee/a790a804-2e43-4901-8d7d-0c656c464f0f)

Company: https://www.keypedia.com/companies/lonza-ag/ae6ae7d7-accc-487a-8d1c-6de734a1944b

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