# FDA 483 - Lonza Biologics, Inc. - February 06, 2026

Source: https://www.keypedia.com/records/483/lonza-biologics-inc/6673b307-3165-470e-bad9-c55bdebe90ed

> FDA 483 for Lonza Biologics, Inc. on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a drug substance manufacturer, revealed four significant observations. These included inadequate laboratory control mechanisms for impurity estimation, deficiencies in the equipment cleaning program, failure to adhere to aseptic behaviors and techniques, and a lack of qualification for non-compendial reference standards. The findings indicate several areas where the firm's quality systems and manufacturing practices require improvement to ensure product quality and safety.

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## Related Officers

- [Sean R. Marcissin](https://www.keypedia.com/people/sean-r-marcissin/3cee7868-b7ea-477b-add3-218b9e7c5285)
- [Emmanuel Duyile](https://www.keypedia.com/people/emmanuel-duyile/cbe875d8-1727-48ee-a6ac-1f7b30943c10)

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

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