# FDA 483 - Lonza Houston, Inc - December 10, 2020

Source: https://www.keypedia.com/records/483/lonza-houston-inc/f76f8011-47f3-43b0-b2ad-55b6f6aa2545

> FDA 483 for Lonza Houston, Inc on December 10, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Houston, Inc
- Inspection Date: 2020-12-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Lonza Houston, Inc. in Houston, TX, revealed significant deficiencies across multiple areas of their viral vector manufacturing operations. The firm was cited for inadequate physical and electronic control of material storage, failure to verify the identity of incoming raw materials, non-adherence to written procedures, and insufficient microbial contamination controls. These observations indicate a need for improved adherence to Good Manufacturing Practices to prevent product mix-ups, ensure material quality, and maintain aseptic conditions.

## Related Documents

- [483 - 2020-12-10](https://www.keypedia.com/records/483/lonza-houston-inc/5cdcb9b9-0c89-4149-9906-e3e9e49b2fd7)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.keypedia.com/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)
- [Compliance Officer at FDA](https://www.keypedia.com/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

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