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# Warning Letters to 4 Homeopathic Drug Makers
- URL: https://www.fdaweb.com/warning-letters-to-4-homeopathic-drug-makers/
- Published: 2019-04-01T12:00:00.000Z
- Updated: 2026-09-15T01:17:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143749

FDA has posted Warning Letters to four companies who produce homeopathic drug products, citing them for significant GMP violations. One letter was sent to King Bio (Asheville, NC), a firm the agency issued a [safety alert](http://app.info.fda.gov/e/er?utm%5Fcampaign=FDA%20warns%20homeopathic%20firms%20for%20putting%20patients%20at%20risk&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=4756&elqTrackId=96BBE5430EEC7D4D506792AFBEA3748A&elq=cb0bb0137ae34cd8bd00eb5a8a20c480&elq) about 8/2018\. The [Warning Letter](http://app.info.fda.gov/e/er?utm%5Fcampaign=FDA%20warns%20homeopathic%20firms%20for%20putting%20patients%20at%20risk&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7240&elqTrackId=D6F94539A256CD149DC129E41AD3F937&elq=cb0bb0137ae34cd8bd00eb5a8a20c480&elqaid=7410&elqat=1) to King Bio cites flaws in manufacturing operations and quality assurance systems found during a 7/2018 FDA inspection, which collected evidence indicating recurring microbial contamination associated with the water system used to manufacture drugs.

The three other Warning Letters were issued to:

- **Red Mountain Incorporated, Oakland Park, FL** — [Warning Letter](http://app.info.fda.gov/e/er?utm%5Fcampaign=FDA%20warns%20homeopathic%20firms%20for%20putting%20patients%20at%20risk&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7236&elqTrackId=F4DA6EC615C50F47E991F74AEADB4F68&elq=cb0bb0137ae34cd8bd00eb5a8a20c480&elqaid=7410&elqat=1) for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
- **Tec Laboratories Incorporated, Albany, OR** — [Warning Letter](http://app.info.fda.gov/e/er?utm%5Fcampaign=FDA%20warns%20homeopathic%20firms%20for%20putting%20patients%20at%20risk&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7235&elqTrackId=680C01830B4E5ACF1578C448F9628379&elq=cb0bb0137ae34cd8bd00eb5a8a20c480&elqaid=7410&elqat=1) 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](http://app.info.fda.gov/e/er?utm%5Fcampaign=FDA%20warns%20homeopathic%20firms%20for%20putting%20patients%20at%20risk&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7234&elqTrackId=B56E552550B5698CB7F2B7900EE36435&elq=cb0bb0137ae34cd8bd00eb5a8a20c480&elqaid=7410&elqat=1) after FDA investigators observed insects in the facility and in ingredients used to make its products.