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CHPA Manufacturing Controls Seminar In Brief

This article was originally published in The Tan Sheet

Executive Summary

Tainted "supplement" recalls soar: Products marketed as dietary supplements but containing active pharmaceutical ingredients were the subject of 80 class I recalls through the first three quarters of fiscal 2010 - compared to slightly more than 50 in 2009 and 10 in each of 2008 and 2007. Adulterated supplements are "blowing this off the chart," says Mike Smedley, deputy director of FDA's Division of Manufacturing Product Quality in the drug center's Office of Compliance. Rx and OTC pharmaceuticals together have totaled fewer than 20 class I recalls in 2010, said Smedley, speaking at the Consumer Healthcare Products Association's Manufacturing Controls Seminar Oct. 13-14 in New Brunswick, N.J. A class I recall is the most serious, denoting a product has potential to cause adverse health effects or death. Smedley said DMPQ recently established a data analysis team to identify root causes of recalls that may trend across multiple firms. FDA has prioritized enforcement against adulterated supplements, which often are marketed for weight loss, strength training or sexual enhancement (1"The Tan Sheet" June 21, 2010)

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