Bachem Americas, Inc. – FDA 483, May 20, 2026

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.