# FDA 483 - Lonza Biologics, Inc. - May 03, 2026

Source: https://www.keypedia.com/records/483/lonza-biologics-inc/08a78762-4e0e-4a56-a33b-83627059e06a

> FDA 483 for Lonza Biologics, Inc. on May 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2026-05-03
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: The FDA inspected Lonza Biologics, Inc. in Hopkinton, MA, a manufacturer of drug substance, revealing significant deficiencies. The firm failed to adequately investigate out-of-specification results, ensure timely completion of investigations, and maintain proper quality control over materials and processes for Ontak and Increlex drug substances. Additionally, issues were noted with equipment maintenance, cleaning validation, and comprehensive employee training.

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [FDA Investigator - Drugs Team at US Department of Health and Human Services](https://www.keypedia.com/people/rory-geyer/9f164dc5-df4d-4ecd-83d0-60fe6e73cf22)

Company: https://www.keypedia.com/companies/lonza-biologics-inc/65c37877-cae1-4065-aca5-ae3cddfb008a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94