# FDA 483 - Bachem Americas, Inc. - March 20, 2023

Source: https://www.keypedia.com/records/483/bachem-americas-inc/b775de2e-479e-4735-98c6-c765d1e002b4

> FDA 483 for Bachem Americas, Inc. on March 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2023-03-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Bachem Americas, Inc. in Vista, CA, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in the quality unit's oversight, including inadequate investigations into water system microbial contamination and batch record errors. Furthermore, the quality unit lacked independence from production, and there were widespread failures in employee GMP training. The facility's warehouse also exhibited poor maintenance and conditions conducive to pest activity.

## Related Documents

- [EIR - 2017-02-10](https://www.keypedia.com/records/eir/bachem-americas-inc/d4d63fc5-039b-4328-a466-e75e3dea2555)
- [483 - 2017-02-10](https://www.keypedia.com/records/483/bachem-americas-inc/7ccbb52d-8066-427b-b84f-7cfe2e5b0e78)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

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