Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters
This article was originally published in The Tan Sheet
About 13% of the 156 warning letters FDA sent to dietary supplement firms from 2011 through June 2014 cited firms for failing to report serious adverse events or for not providing on product labels a domestic address or phone number at which to receive AERs. The citation total has climbed steadily from 2011.
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