FDA EIR - Bachem Americas, Inc. - March 27, 2023

Bachem Americas, Inc. underwent a comprehensive surveillance inspection by the FDA from March 20 to March 27, 2023, focusing on its Active Pharmaceutical Ingredient (API) manufacturing for human drugs. The inspection was conducted under the CPGM 7356.002F-(API) PROCESS INSPECTION and ICH Q7 Good Manufacturing Practice Guide for APIs. The FDA issued a four-item Form 483, Inspectional Observations, highlighting several critical issues.

Main violations included a failure of the quality unit to ensure API compliance with current Good Manufacturing Practices (CGMP), a lack of independence of the quality unit from production, and its inability to fully fulfill quality assurance and quality control duties. Furthermore, the inspection identified a failure to ensure employees, including the Site Manager, received regular, qualified CGMP training relevant to their operations. Lastly, the company failed to properly maintain its buildings and facilities in a clean condition, with observations of unsealed doors, debris accumulation, and pest control deficiencies.

Bachem Americas, Inc. initiated some voluntary corrections during the inspection, such as addressing building deficiencies and equipment status tags, and revising an SOP. Management, including the Site Manager and the VP of Quality and Regulatory Affairs, acknowledged the observations and committed to providing a written response to the FDA Form 483 within fifteen business days, outlining their planned corrective and preventive actions.