# FDA 483 - Bachem Americas, Inc. - June 03, 2019

Source: https://www.keypedia.com/records/483/bachem-americas-inc/8bcb8500-97a7-496a-8f3f-be434585a7e2

> FDA 483 for Bachem Americas, Inc. on June 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2019-06-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Bachem Americas, Inc. in Torrance, CA, revealed a significant deficiency in their quality system. The firm failed to adequately determine the cause of out-of-specification (OOS) test results, specifically in three reviewed investigations related to materials used in commercial API manufacturing. This indicates a moderate severity issue concerning quality control and investigation processes.

## Related Documents

- [483 - 2018-11-20](https://www.keypedia.com/records/483/bachem-americas-inc/85cd5768-2511-46f6-8795-fe3f9f2cdee0)
- [483 - 2019-12-10](https://www.keypedia.com/records/483/bachem-americas-inc/faf07fe9-f67c-4c30-8ca8-5e73658d8174)

## Related Officers

- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/bachem-americas-inc/3a9656ad-737b-4682-9ab3-951b1041002e

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