# FDA 483 - Bachem Americas, Inc. - December 10, 2019

Source: https://www.globalkeysolutions.net/records/483/bachem-americas-inc/faf07fe9-f67c-4c30-8ca8-5e73658d8174

> FDA 483 for Bachem Americas, Inc. on December 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2019-12-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Bachem Americas, Inc. in Torrance, CA, an API manufacturer, received a Form 483 for deficiencies in their operations. The inspection revealed incomplete batch production records, insufficient investigation into purified water system contamination, and inadequate qualification of contract laboratories. These observations highlight concerns regarding documentation, quality control, and supplier management.

## Related Documents

- [483 - 2018-11-20](https://www.globalkeysolutions.net/records/483/bachem-americas-inc/85cd5768-2511-46f6-8795-fe3f9f2cdee0)
- [483 - 2019-06-03](https://www.globalkeysolutions.net/records/483/bachem-americas-inc/8bcb8500-97a7-496a-8f3f-be434585a7e2)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

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

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