# FDA 483 - Bachem Americas, Inc. - November 20, 2018

Source: https://www.keypedia.com/records/483/bachem-americas-inc/85cd5768-2511-46f6-8795-fe3f9f2cdee0

> FDA 483 for Bachem Americas, Inc. on November 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2018-11-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Bachem Americas, Inc. was cited for multiple quality system deficiencies during an FDA inspection. Observations included untimely review and approval of quality investigation documents, late annual product reviews, and overdue preventive maintenance on production equipment. Additionally, the firm failed to conduct timely supplier and contract laboratory audits and exhibited deficiencies in batch record completeness and data security for analytical equipment.

## Related Documents

- [483 - 2019-06-03](https://www.keypedia.com/records/483/bachem-americas-inc/8bcb8500-97a7-496a-8f3f-be434585a7e2)
- [483 - 2019-12-10](https://www.keypedia.com/records/483/bachem-americas-inc/faf07fe9-f67c-4c30-8ca8-5e73658d8174)

## Related Officers

- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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