Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters

21 Jul 2014

• By Elizabeth Crawford

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.

FDA increasingly is citing dietary supplement firms for violations of adverse event reporting requirements that agency officials find during good manufacturing practice inspections, according to an analysis of warning letters.

Inspectors are checking that firms meet the basic requirements, and looking at how firms benchmark the data to evaluate other...