# FDA 483 - Bachem Americas, Inc. - February 10, 2017

Source: https://www.keypedia.com/records/483/bachem-americas-inc/7ccbb52d-8066-427b-b84f-7cfe2e5b0e78

> FDA 483 for Bachem Americas, Inc. on February 10, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2017-02-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Bachem Americas, Inc. in Vista, CA, revealed two significant observations. The firm failed to implement appropriate controls over computer systems, specifically a titrator used for API moisture content, lacking validation and unauthorized data control. Additionally, a leaking plumbing system was observed near the manufacturing area, posing a contamination risk to drug products.

## Related Documents

- [EIR - 2017-02-10](https://www.keypedia.com/records/eir/bachem-americas-inc/d4d63fc5-039b-4328-a466-e75e3dea2555)
- [483 - 2023-03-20](https://www.keypedia.com/records/483/bachem-americas-inc/b775de2e-479e-4735-98c6-c765d1e002b4)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.keypedia.com/companies/bachem-americas-inc/f0157d2d-6b0c-4b13-afd4-551c2ab94aad

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