# FDA 483 - Lonza Bend Inc. - May 24, 2023

Source: https://www.globalkeysolutions.net/records/483/lonza-bend-inc/ff6ae813-1b31-4354-be67-294b2f60902c

> FDA 483 for Lonza Bend Inc. on May 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Bend Inc.
- Inspection Date: 2023-05-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Lonza Bend Inc., a contract drug manufacturer in Bend, OR, revealed significant deficiencies across its quality system. Observations included inadequate controls over computerized systems and data integrity, issues with equipment design and qualification, and a critical failure in component identity testing for drug products, specifically regarding toxic glycol derivatives in pediatric formulations. These findings indicate a high severity of non-compliance impacting product quality and patient safety.

## Related Documents

- [483 - 2018-07-27](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/a286ffb4-d50d-4b25-aa88-6d654fe832fa)
- [483 - 2022-08-05](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/8b51d03e-655e-4357-92ad-22a1fd139bff)

## Related Officers

- [Huiquan Wu](https://www.globalkeysolutions.net/people/huiquan-wu/4ad517d3-3f93-491b-94b4-02a1a0bb76e4)
- [Hung H. Do](https://www.globalkeysolutions.net/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.globalkeysolutions.net/companies/lonza-bend-inc/35de45c5-ab00-4ab8-a472-a01f6edc8897

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822