# FDA 483 - Lonza Biologics, Inc. - June 06, 2025

Source: https://www.globalkeysolutions.net/records/483/lonza-biologics-inc/b183451f-e08e-4fc2-b16f-6016c1be5c25

> FDA 483 for Lonza Biologics, Inc. on June 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2025-06-06
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Lonza Portsmouth, Inc. in Portsmouth, NH, revealed significant deficiencies in the manufacturing of CASGEVY drug product. Observations included inadequate aseptic processing, cleaning procedures, documentation practices, and HVAC controls. The firm also demonstrated weaknesses in deviation management, environmental monitoring, sterility testing, and pest control programs.

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- [483 - 2025-06-06](https://www.globalkeysolutions.net/records/483/lonza-biologics-inc/7e2c12cc-7bee-4578-9e3c-7e55036f3e8e)

## Related Officers

- [Timothy Kamaldinov](https://www.globalkeysolutions.net/people/timothy-kamaldinov/30dbc3a4-c383-4c18-9d4b-a3b1e6f50860)
- [Lead Consumer Safety Officer](https://www.globalkeysolutions.net/people/xiuju-lu/90517f8a-e5ac-44a9-b2a2-3358e114754f)
- [issuing_officer](https://www.globalkeysolutions.net/people/kinjal-s-patel/95b05da2-7138-4443-8667-1338137bd785)
- [Biologist at CBER](https://www.globalkeysolutions.net/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)
- [Athena L. Russell](https://www.globalkeysolutions.net/people/athena-l-russell/d9722ca6-29c6-4528-ad7d-4db453c1942d)

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