FDA 483 - Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals - January 31, 2025

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals in San Rafael, CA, was cited with three observations during an FDA inspection. The inspection revealed significant issues including the failure to validate microbial testing methods, inadequate quality control unit procedures and investigation practices, and a lack of qualification for a third-party component supplier. These deficiencies indicate a systemic breakdown in quality assurance for their homeopathic drug products.