Monday, April 1, 2019

FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio. 

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as 

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