A 31 January warning to Les Importations Herbasanté Inc., in Saint-Laurent, QC, is the latest evidence of an homeopathic firm not being aware the US regulates the category with the same requirements it has for other OTC and Rx formulations.

FDA officials in an August inspection found that Importations Herbasanté, a contract manufacturer, failed to perform adequate identity testing of each drug component lot used in the manufacture of its drugs, including products intended for infants and children, and relied on its suppliers’ COA without establishing the reliability of its suppliers’ testing at appropriate intervals, the warning states.

The firm’s violations also including failing to validate its manufacturing processes, a requirement it wasn't aware of it told FDA officials.

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