FDA EIR - Boehringer Ingelheim Fremont, Inc. - November 04, 2022

An FDA inspection of Boehringer Ingelheim Fremont, Inc., a biopharmaceutical drug substance and drug product manufacturer in Fremont, CA, was conducted from October 25 to November 4, 2022. Initially slated as a pre-approval inspection for Cyltezo (adalimumab-adbm), it was re-scoped as a GMP surveillance inspection. The regulatory framework for this inspection was compliance program 7356.002M, focusing on Licensed Biological Therapeutic Drug Products, and covered Biotechnology derived API (CBI) and Sterile-filled small volume parenterals (SVS) profile codes.

The main violation documented on a Form FDA 483 was that the responsibilities and procedures for the quality control unit were not adequately established in writing and fully followed. Additional issues discussed with management included adhesive residue found in ISO 8 production rooms, process validation manufacturing runs with unmet yield requirements, deviations investigations not closing by their due dates, and the failure to track SOP revisions related to deviations as corrective actions. Concerns also encompassed leaking in-process product due to inadequate material, excessive non-viable particle excursions, lack of required reserve sample review in annual reports, and an email policy automatically deleting potentially crucial GMP records.

Boehringer Ingelheim Fremont, Inc. management committed to submitting a written response addressing the FDA 483 observation and all discussed findings to the FDA San Francisco District Office within 15 working days.