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

Source: https://www.keypedia.com/records/483/lonza-biologics-inc/cf15e3d3-5f91-42e8-9b9d-a5cece43b8c8

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

---

## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2025-06-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Lonza Portsmouth, Inc. was inspected regarding its drug product manufacturing operations for CASGEVY. The inspection revealed significant deficiencies in aseptic processing, facility cleaning, documentation practices, HVAC controls, deviation management, environmental monitoring, and sterility testing. These issues indicate a broad lack of control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2020-11-03](https://www.keypedia.com/records/483/lonza-biologics-inc/1c4dc8ba-78a2-4438-b100-d4cfaa927f37)
- [EIR - 2020-11-03](https://www.keypedia.com/records/eir/lonza-biologics-inc/3d44ec3c-8d8b-4191-86f7-37a1e679a7ab)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/lonza-biologics-inc/6e82b09e-669e-408f-9fb6-6063c2bbc0b0)
- [483 - 2023-07-21](https://www.keypedia.com/records/483/lonza-biologics-inc/868ee773-89d9-4285-aa55-f226970279fa)
- [483 - 2024-03-07](https://www.keypedia.com/records/483/lonza-biologics-inc/a5417b6a-1ebe-4cd5-8ba7-eae412f0931f)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4