FDA 483 - Bachem Americas, Inc. - May 20, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · b5ea1362-15ad-4f14-9def-d87aa209124f