其 他 安 全 警 示
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| The United States: FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards (English Only) |
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The US Food and Drug Administration (FDA) announces that it 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 homeopathic drug products manufactured by King Bio.
The FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations. These companies are:
- 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm634885.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by the above four companies. Related news on products by King Bio Inc. was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 21 Jul 2018, with the latest update posted on 11 Oct 2018.
Ends/Tuesday, Apr 2, 2019
Issued at HKT 15:00
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