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

Source: https://www.keypedia.com/records/warning_letter/nova-homeopathic-therapeutics-inc/da4725f6-e2fe-4d0e-bb7d-47ce17aa37cc

> FDA WARNING_LETTER for Nova Homeopathic Therapeutics Inc on October 12, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nova Homeopathic Therapeutics Inc
- Inspection Date: 2016-10-12
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: 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.
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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/nova-homeopathic-therapeutics-inc/eb7f5a65-74fd-4b2e-a99e-29f433dac4be

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b