# FDA 483 - Bachem Americas, Inc. - May 20, 2026

Source: https://www.keypedia.com/records/483/bachem-americas-inc/b5ea1362-15ad-4f14-9def-d87aa209124f

> FDA 483 for Bachem Americas, Inc. on May 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bachem Americas, Inc.
- Inspection Date: 2026-05-20
- Product Type: drugs
- Office Name: FDA District Office — Irvine, California
- Summary: Bachem Americas, Inc. in Vista, CA, an API manufacturer, received a Form FDA-483 with eight observations. The inspection revealed significant deficiencies in quality unit oversight, including failures in drug substance release testing, stability program management, laboratory investigations, reserve sample handling, instrument qualification, and reference standard controls. Additionally, the facility exhibited poor building and facility maintenance, leading to potential contamination and material mix-ups.

## Related Documents

- [EIR - 2023-03-27](https://www.keypedia.com/records/eir/bachem-americas-inc/036253c7-38bb-445a-9467-c594e5dea685)
- [483 - 2017-02-10](https://www.keypedia.com/records/483/bachem-americas-inc/7ccbb52d-8066-427b-b84f-7cfe2e5b0e78)
- [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

- [Navneet Kaur](https://www.keypedia.com/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)
- [Tareq W. Haddad](https://www.keypedia.com/people/tareq-w-haddad/5dcb10ba-950c-4dea-b351-0b129675f6d2)
- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [Kamyl GUZMAN MORALES](https://www.keypedia.com/people/kamyl-guzman-morales/7dab4749-71f9-4324-828e-f2fc8dfb9038)

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

Office: https://www.keypedia.com/offices/fda-district-office-irvine-california/c55c1fae-d723-42b5-83f6-70b2d576d724