# FDA 483 - Lonza Houston, Inc - November 18, 2025

Source: https://www.keypedia.com/records/483/lonza-houston-inc/e418f58e-2cfe-4e4a-b05c-26a75097a51a

> FDA 483 for Lonza Houston, Inc on November 18, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Houston, Inc
- Inspection Date: 2025-11-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Lonza Houston, Inc. in Houston, TX, received a Form 483 for significant deficiencies in its aseptic processing areas, primarily concerning microbial contamination control. The inspection revealed numerous environmental monitoring excursions, adverse trends of mold and bacterial recoveries, and subsequent impact on drug substance batches. Additionally, the firm failed to adequately extend investigations of discrepancies to all potentially affected drug product batches.

## Related Documents

- [483 - 2020-12-10](https://www.keypedia.com/records/483/lonza-houston-inc/f76f8011-47f3-43b0-b2ad-55b6f6aa2545)
- [EIR - 2020-12-10](https://www.keypedia.com/records/eir/lonza-houston-inc/69db7a95-168c-4a69-b1bd-bb1554c5ff03)
- [483 - 2020-12-10](https://www.keypedia.com/records/483/lonza-houston-inc/5cdcb9b9-0c89-4149-9906-e3e9e49b2fd7)
- [EIR - 2022-02-18](https://www.keypedia.com/records/eir/lonza-houston-inc/9dbe5d45-4d0c-49af-997c-4fea18914efa)

## Related Officers

- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)

Company: https://www.keypedia.com/companies/lonza-houston-inc/c3ae4db9-9aba-4b65-9e2b-06e1632112a6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab