# FDA 483 - Lonza Bend Inc. - May 19, 2026

Source: https://www.keypedia.com/records/483/lonza-bend-inc/3be12913-2ef2-4162-a594-fc55b54c498a

> FDA 483 for Lonza Bend Inc. on May 19, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Bend Inc.
- Inspection Date: 2026-05-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Lonza Bend Inc. in Bend, OR, was cited for failing to thoroughly review unexplained discrepancies and trend deviations to prevent recurrence. The inspection revealed repeat issues related to gasket failures, data loss and storage discrepancies, and missing manufacturing documentation, indicating significant quality system deficiencies.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [ analyst /Microbiologist ](https://www.keypedia.com/people/ana-maria-a-plapcianu/5f370fbd-8ff9-4fcf-ad57-380201abc7cd)
- [Conor J. Mccarron](https://www.keypedia.com/people/conor-j-mccarron/280401e4-b080-4ba8-ab35-d3b16e91c2b1)
- [Eric Zhu](https://www.keypedia.com/people/eric-zhu/32919a8f-841a-441b-a489-8495f2e16993)

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

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