Forces of Nature, Inc. – FDA 483, Jan 20, 2023

An FDA inspection of Forces of Nature, Inc. in Sonoma, CA, a manufacturer of homeopathic drugs, revealed significant deficiencies across multiple systems. The firm failed to establish adequate production and process controls, maintain proper documentation for deviations, ensure component testing, and manage complaints effectively. Additionally, issues were noted in employee training, equipment cleaning, stability testing, and reserve sample management, indicating a broad lack of adherence to good manufacturing practices.