# FDA 483 - Lonza Bend Inc. - July 27, 2018

Source: https://www.globalkeysolutions.net/records/483/lonza-bend-inc/a286ffb4-d50d-4b25-aa88-6d654fe832fa

> FDA 483 for Lonza Bend Inc. on July 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Bend Inc.
- Inspection Date: 2018-07-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Bend Research Inc. in Bend, OR, was inspected and cited for significant deficiencies in its manufacturing processes. Observations include a lack of written procedures and controls for critical production operations, inadequate qualification of manufacturing equipment and vision systems, and a failure to thoroughly investigate and document manufacturing discrepancies. These issues indicate a systemic weakness in their quality control and assurance systems.

## Related Documents

- [483 - 2022-08-05](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/8b51d03e-655e-4357-92ad-22a1fd139bff)
- [483 - 2023-05-24](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/ff6ae813-1b31-4354-be67-294b2f60902c)

## Related Officers

- [Chiacchun J Wang](https://www.globalkeysolutions.net/people/chiacchun-j-wang/73e26ee5-9d66-42aa-a8be-86043b7ec6e8)
- [Zachary A. Bogorad](https://www.globalkeysolutions.net/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

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