Bachem Americas, Inc. – FDA 483, Mar 20, 2023

Bachem Americas, Inc. in Vista, CA, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in the quality unit's oversight, including inadequate investigations into water system microbial contamination and batch record errors. Furthermore, the quality unit lacked independence from production, and there were widespread failures in employee GMP training. The facility's warehouse also exhibited poor maintenance and conditions conducive to pest activity.