# FDA 483 - Lonza Bend Inc. - August 05, 2022

Source: https://www.globalkeysolutions.net/records/483/lonza-bend-inc/8b51d03e-655e-4357-92ad-22a1fd139bff

> FDA 483 for Lonza Bend Inc. on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Bend Inc.
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Bend Research, Inc. in Bend, OR, a contract manufacturer, revealed significant deficiencies in their quality system regarding investigations of unexplained discrepancies. The firm failed to extend investigations to all affected batches and frequently closed investigations without definitive root causes or corrective actions. These issues could result in the distribution of non-conforming drug products.

## Related Documents

- [483 - 2018-07-27](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/a286ffb4-d50d-4b25-aa88-6d654fe832fa)
- [483 - 2023-05-24](https://www.globalkeysolutions.net/records/483/lonza-bend-inc/ff6ae813-1b31-4354-be67-294b2f60902c)

## Related Officers

- [Nathaniel B. Phillips-Sylvain](https://www.globalkeysolutions.net/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)
- [Crystal Monroy](https://www.globalkeysolutions.net/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6