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Posted July 15, 2011

FDA Inspection Finds Manufacturing Problems with Several Supplements Including Women's Multivitamin

The U.S. FDA recently posted a Warning Letter sent to BioSan Laboratories of Derry, New Hampshire on June 17, 2011 concerning multiple violations of Good Manufacturing Practice regulations and labeling rules. Products affected by the violations include the dietary supplements Megaflora, Adrenal Refresh, and Women over 40 Daily.

The violations were first noted during an inspection by the FDA in January 2011. The FDA also notes that BioSan's responses to date on several violations have been inadequate.

Among the violations are the following:

- A failure to perform appropriate identity tests or examination on vitamins, minerals, or botanicals used in the Women Over 40 One Daily supplement.

- A certain lot of Adrenal Response was distributed in 2010 although it failed to meet all product specifications.

- Addition of botanical ingredients in the Women Over 40 One Daily dietary supplement and the Adrenal Response dietary supplement that did not meet microbiological specifications.

In reviewing product labels, the FDA noted that the MegaFlora dietary supplement was misbranded because it failed to declare the amount of Vitamin C in the “Supplement Facts” panel and the Adrenal Refresh dietary supplement was misbranded because it failed to identify the part of the plant (e .g., root, leaves) from which botanical dietary ingredients in the product are derived. For example, the product lists the ingredients Rodiola extract and gooseberry, but does not identify the part of the plants used. Adrenal Refresh also failed to bear a domestic address or domestic phone number to which a person may report a serious adverse event.

The FDA noted that although supplement companies are required to submit adverse event reports to the FDA within 15 business days after receiving such reports, Biosan did not report a serious adverse event received in October 2010 until February 2011.

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