FDA 483 - Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals - January 28, 2020

Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals, a homeopathic drug manufacturer in San Rafael, CA, was inspected and cited for significant deficiencies across multiple quality systems. The inspection revealed failures in component rejection, supplier validation, test method validation, quality control unit procedures, and cGMP training for quality personnel. These issues indicate a systemic lack of adherence to good manufacturing practices.