# FDA 483 - Lonza Biologics, Inc. - July 21, 2023

Source: https://www.globalkeysolutions.net/records/483/lonza-biologics-inc/868ee773-89d9-4285-aa55-f226970279fa

> FDA 483 for Lonza Biologics, Inc. on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, revealed a significant issue regarding the qualification of critical manufacturing equipment. The firm failed to adequately qualify a Grade A bottle filler, specifically in demonstrating unidirectional airflow during both static and dynamic operations. This deficiency raises concerns about the control of the aseptic processing environment for drug substance manufacturing.

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## Related Officers

- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7