Nova Homeopathic Therapeutics Inc FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 01, 2017
Executive Summary
The FDA issued a warning letter to Nova Homeopathic Therapeutics Inc on September 01, 2017 citing regulatory violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Nova Homeopathic Therapeutics Inc's operations or product claims.
Potential Health Risks
Division of Pharmaceutical Quality Operations IV19701 Fairchild RoadLos Angeles, CA 92612
A risk assessment for distributed drug products you manufactured using an unvalidated process. Address the potential effects of your lack of validation on all products intended for vulnerable populations, such as infants and children, distributed within the United States, and still within expiry.
“Liver congestion and dysfunction due to toxic overload from alcohol and pharmaceutical drugs.”
Regulatory Context
A data-driven and scientifically sound validation protocol to ensure that you will identify and control all sources of variability in your drug manufacturing processes to ensure that all of your drugs consistently meet appropriate quality attributes.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Nova Homeopathic Therapeutics Inc?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Nova Homeopathic Therapeutics Inc products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used Nova Homeopathic Therapeutics Inc products?
- If you have used products from Nova Homeopathic Therapeutics Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter