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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GnuPharma Corp., Grandma's herbs Inc. and Madison Once Acme Inc. are the most recent supplement manufacturers and marketers hit with ORA warning letters on problems from GMP deficiencies to failing investigate an AER.
Robust dietary supplement adverse event compliance systems can support faster identification of problems and improve products, says Nature’s Bounty Product Vigilance Manager Christina Romano. During a recent CRN webinar, she said distributors, retailers and researchers should be part of the reporting system.
FDA warns own-labelers ProSupps USA and Cape Fear Naturals about GMP violations, also pointing out ProSupps dropped the ball on submitting serious AERs to FDA and Cape Fear Naturals made drug claims including “improve blood pressure and cholesterol.”