Bachem Americas, Inc. – FDA EIR, Feb 10, 2017

An FDA Pre-Approval Inspection (PAI) was conducted at Bachem Americas, Inc. in Vista, CA, from February 7-10, 2017. The inspection was a response to a New Drug Application (NDA) Prior Approval Supplement (PAS) for transferring the manufacturing and testing site of an active pharmaceutical ingredient (API) peptide. The inspection identified two significant observations, resulting in an FDA-483 being issued. First, the company failed to exercise appropriate controls over computer systems for a titrator used to determine the moisture content of the API. This instrument lacked validation, password protection, time records, and audit trails, compromising data reliability for critical submission and stability testing batches. Second, defects were noted in the facility's plumbing system, specifically a leaking water tank in the water system that could potentially contaminate drug products, violating 21 CFR 211.48(a). Management, represented by the Chief Operating Officer, acknowledged the observations and committed to submitting a formal response within 15 business days. The company demonstrated immediate corrective action by repairing the leaking tank during the inspection. This PAI aimed to ensure the facility's readiness for commercial drug substance production.