# FDA 483 - Lonza Biologics, Inc. - April 16, 2026

Source: https://www.keypedia.com/records/483/lonza-biologics-inc/7b621acc-25b2-419b-b47c-63946c125023

> FDA 483 for Lonza Biologics, Inc. on April 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2026-04-16
- Product Type: drugs
- Office Name: New England District Office
- Summary: Lonza Biologics, Inc. in Portsmouth, NH, was inspected and received a Form 483 with three observations related to significant manufacturing and quality control deficiencies for their CASGEVY drug product. The inspection revealed a lack of process control over CASGEVY manufacturing, failures in preventing microbiological contamination of sterile products, and inadequate warehousing procedures for final drug product vials. These issues indicate a serious lack of adherence to good manufacturing practices.

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## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)

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