FDA EIR - Bachem Americas, Inc. - February 23, 2022

An FDA Pre-Approval and cGMP inspection of Bachem Americas, Inc., a bulk drug substance manufacturer in Torrance, CA, was conducted from February 18-23, 2022. The inspection, guided by CPGM 7346.832 and 7356.002F, focused on compliance with the Federal Food, Drug, and Cosmetic Act. Notably, no formal FDA-483 observations were issued. However, the agency discussed several areas for improvement with management. Key issues included an insufficient corrective action plan following a temperature probe investigation, which lacked broader equipment evaluation. Batch production records for one product exhibited unclear instructions regarding operational parameters and ranges. Furthermore, raw material storage areas showed organizational deficiencies, such as a lack of designated staging, hidden labels, and pallets obstructing cleaning and pest control. The inspection also highlighted that quality management was not fully proficient with recall procedures, and mock-recall exercises were conducted too infrequently. Bachem's management acknowledged these findings and committed to reviewing them for enhanced compliance and operational clarity.