Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)

You may also be interested in...



CDER Enforcement Priorities Include Quality Control, Drug "Criminalization"

FDA's Center for Drug Evaluation and Research will crack down on manufacturers that attempt to "farm out responsibility," firms that fail to meet reporting requirements and the general "criminalization of our drug supply," said Deb Autor, director of the center's compliance office

FDA Will Enforce NDI Notification Requirement Without Warning

FDA likely will not issue warnings before taking judicial actions against firms that fail to comply with the new dietary ingredient notification regulation once the agency publishes a long-awaited guidance

People In Brief

Perrigo promotes in pricing, planning

Topics

UsernamePublicRestriction

Register

PS104620

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel