FDA WARNING_LETTER - Nova Homeopathic Therapeutics Inc - October 12, 2016

The FDA inspected Nova Homeopathic Therapeutics, Inc. from October 3-12, 2016, identifying significant CGMP violations and misbranded drug products. The firm's drug products are adulterated under 21 U.S.C. 351(a)(2)(B) due to non-conforming manufacturing methods, facilities, or controls. Products Depression Complex, Circulation Complex, and Liver Complex are misbranded under 21 U.S.C. 353(b) and 352(f)(1).

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** The firm lacks a QCU with authority to approve/reject materials and products (21 CFR 211.22(a)). There are no adequate written procedures for QCU responsibilities, complaint handling, annual product review, stability studies, or material/product release. The firm stated unawareness of CGMP requirements for homeopathic drugs despite manufacturing since 1983. 2. **Failure to Test Components:** The firm did not test components for identity, purity, strength, or quality before use (21 CFR 211.84(d)(1) & (2)), including belladonna mother tincture and ethyl alcohol. A component used in all products was labeled "Not intended as a Drug Substance," with no scientific evidence of USP compliance. 3. **