FDA EIR - Bachem Americas, Inc. - May 18, 2018

Bachem Americas, Inc. underwent an unannounced routine FDA inspection for current Good Manufacturing Practices (cGMP) of Active Pharmaceutical Ingredients (API) from May 10-18, 2018. The inspection, conducted under regulatory frameworks including CPGM 7356.002F, CPGM 7371.001, and ICH Q7, focused on the Quality, Facilities and Equipment, Materials, and Production Systems.

The inspection identified six main violations documented on FDA Form 483. Key issues included the Quality Assurance department's failure to timely review and approve quality system investigation documents, and non-adherence to established procedures for product reviews, resulting in late reporting. The company also failed to perform preventive maintenance on production equipment and neglected to conduct timely qualification audits for component and raw material suppliers and contract laboratories. Additionally, a specific API's production batch record was found to not capture all critical process steps, and a UV spectrophotometer used for in-process testing exhibited data security deficiencies in its computer operating system and software.

Bachem Americas' management acknowledged the observations and committed to providing a formal written response to the FDA within fifteen business days, along with a promise to implement necessary corrective actions.