Warnings In 2019, AERs In 2009: Touchstones Toward Homeopathic Guidance
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FDA warns OHM Pharma for promoting topical formula containing homeopathic ingredients as teething product for infants. The firm also warned about drug and supplements GMP violations and was an easy target for FDA following release of draft guidance outlining its enforcement priorities.
A revised draft introduces list of risk-based enforcement priorities but doesn't necessarily tighten FDA oversight of homeopathics manufacturing and marketing, say CHPA and AIH.
FDA warning letters require lengthy remediation plans from Kadesh. and two of its contract manufacturers, Fill It Pack It and WePackItAll. The third manufacturer, US Continental Marketing, told FDA it has stopped making drugs.