# FDA 483 - Lonza AG - April 04, 2025

Source: https://www.keypedia.com/records/483/lonza-ag/49d1c9a6-62e9-4d01-a2a3-bb792f53a7b4

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lonza AG, a drug product manufacturer in Visp, Switzerland, was cited for failing to establish and follow procedures designed to prevent microbiological contamination of sterile drug products. Inspectors observed deficiencies during dynamic smoke study videos, including operators covering sterile openings and blocking first air during critical aseptic operations. These issues indicate a lack of adherence to aseptic processing principles.

## Related Officers

- [ 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)
- [Melissa D. Ray](https://www.keypedia.com/people/melissa-d-ray/d3edab82-132c-4a8f-997a-19d610a4f03a)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd