FDA 483 - Schwabe North America, Inc. - August 28, 2025

An FDA inspection of Schwabe North America, Inc. in Green Bay, WI, revealed significant deficiencies in their quality control system. The firm failed to thoroughly investigate unexplained discrepancies and deviations during the manufacturing of homeopathic drug products. This included a lack of comprehensive root cause analysis, product impact assessments, proper documentation, and corrective actions, indicating potential systemic issues.