FDA EIR - Bachem Americas, Inc. - June 12, 2019

An FDA inspection of Bachem Americas, Inc. in Torrance, CA, was conducted from June 3-12, 2019. This unannounced abbreviated inspection focused on the company's Active Pharmaceutical Ingredient (API) manufacturing for both human and veterinary use, adhering to CPGM and ICH Q7 Good Manufacturing Practice guidelines. The inspection reviewed the Quality and Laboratory systems. Prior observations from a 2018 inspection, including issues with quality assurance document review, product reviews, preventive maintenance, supplier audits, batch record accuracy, and data security settings, were verified as corrected. However, the current inspection resulted in a one-item FDA 483 observation. The primary violation identified was the firm's inadequate determination of root causes for Out-of-Specification (OOS) test results in three specific instances. The company's investigations relied on retesting without sufficiently proving the underlying hypotheses for the OOS results. During the closing meeting, a concern regarding employee training records not being consistently updated or reflecting actual job functions was also discussed, though not included on the FDA 483. The site manager acknowledged the OOS observation and committed to providing a written response to the FDA, which could involve corrective actions to improve OOS root cause analysis.