# FDA 483 - Lonza Biologics, Inc. - March 07, 2024

Source: https://www.globalkeysolutions.net/records/483/lonza-biologics-inc/a5417b6a-1ebe-4cd5-8ba7-eae412f0931f

> FDA 483 for Lonza Biologics, Inc. on March 07, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2024-03-07
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a biological drug substance manufacturer, revealed two significant observations. The firm failed to adequately investigate unexplained discrepancies related to calibration data and incorrectly assessed failing data as passing. Additionally, the company did not follow its own established procedures for process descriptions, continuing manufacturing even after critical test failures were identified for bulk drug substances.

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## Related Officers

- [Vijaya L. Simhadri](https://www.globalkeysolutions.net/people/vijaya-l-simhadri/dfae7da4-91e0-4cb4-8b23-afcb351a6e44)
- [Svetlana A. Shestopal](https://www.globalkeysolutions.net/people/svetlana-a-shestopal/5bf58ad5-04c7-4a9b-ae2d-8c6fa4034ddd)
- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/lonza-biologics-inc/f9882ce5-d92a-4c88-916e-8f4e6d1f2aff

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144