FDA Warns Homeopathic Firms for Putting Patients at Risk with Manufacturing Quality Violations

The U.S. Food and Drug Administration (FDA) 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.

The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homeopathic drug products; results revealed inordinately high microbiological contamination. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drugs. The microbiological contamination of the water system led, in part, to a voluntary recall of more than 900 potentially homeopathic drug products manufactured by King Bio. Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.

King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.

The FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations.

Red Mountain Incorporated, Oakland Park, Fla. — warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.

Tec Laboratories Incorporated, Albany, Ore. — warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system

B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India — warning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.

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