# FDA 483 - Lonza Bend Inc - January 24, 2020

Source: https://www.keypedia.com/records/483/lonza-bend-inc/6ec03ead-9a3a-48ab-a43b-52605b2c272f

> FDA 483 for Lonza Bend Inc on January 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Bend Inc
- Inspection Date: 2020-01-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Bend Research, Inc., a control testing laboratory in Bend, OR, identified two significant issues. The firm failed to perform routine inspection and checking of automatic equipment according to a written program, leading to numerous unaddressed system errors. Additionally, the firm did not maintain a backup file of critical data entered into its computer systems, resulting in a loss of historical log information.

## Related Documents

- [EIR - 2016-06-03](https://www.keypedia.com/records/eir/lonza-bend-inc/ec42fdd8-aaa0-4bc9-9977-7b456abbfd7a)
- [EIR - 2017-06-30](https://www.keypedia.com/records/eir/lonza-bend-inc/e0eb212e-0bd2-4d8c-a999-773dab626178)
- [EIR - 2020-01-24](https://www.keypedia.com/records/eir/lonza-bend-inc/b5ec2a9c-02b3-4780-8f82-c9ac8a15551a)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anissa-m-vargas/6ecd277e-84c9-4ca0-abff-d86892229b11)
- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/lonza-bend-inc/d574a9e5-f048-4951-89b0-a789d938c962

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