# FDA 483 - Lonza AG - March 29, 2019

Source: https://www.keypedia.com/records/483/lonza-ag/d2b94531-82a9-47ee-8dfc-06a69d21c1c6

> FDA 483 for Lonza AG on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza AG
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lona Pharma and Biotech in Visp, Switzerland, a drug substance manufacturer, was cited with five observations during an FDA inspection from March 25-29, 2019. The observations primarily concern inadequate testing and storage of intermediates and drug substances, deficiencies in validation studies, and issues with raw material handling, pest control, and QC analytical procedures. These findings indicate significant concerns regarding quality control and manufacturing practices.

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## Related Officers

- [Ralph M. Bernstein](https://www.keypedia.com/people/ralph-m-bernstein/72173dfb-24ae-42a1-af9e-1dc7da02ed87)
- [Reyes Candau-Chacón, Ph.D.](https://www.keypedia.com/people/reyes-candau-chacon-phd/c4e9fd50-2a2b-41a7-9cd0-db29dbb9171a)

Company: https://www.keypedia.com/companies/lonza-ag/7084f7e6-ce36-429f-942a-28e759416e70

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