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

Source: https://www.keypedia.com/records/483/schwabe-north-america-inc/d318bbaf-9144-490d-a9bf-4862e8c9964c

> FDA 483 for Schwabe North America, Inc. on August 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schwabe North America, Inc.
- Inspection Date: 2025-08-28
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

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## Related Officers

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Company: https://www.keypedia.com/companies/schwabe-north-america-inc/ac030767-09e8-4377-99ee-7360176e40ed

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d