HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Only 16% Of Supplement Makers Surveyed Report AEs To FDA - GMP Study

This article was originally published in The Tan Sheet

Executive Summary

A scant 37 (16% of 238) dietary supplement establishments that responded to an FDA manufacturing practices survey said they report consumer complaints of adverse events to FDA.

You may also be interested in...



Supplement GMPs On CFSAN's Autumn "Must Do" List, Levitt Tells CRN

Dietary supplement Good Manufacturing Practices are on the Center for Food Safety & Applied Nutrition's "must do" list for this fall, although a proposed reg will not be issued by the Sept. 30 target deadline, CFSAN Director Joseph Levitt reported.

Fixed-Combination OTCs Derived From Botanicals Due For Rulemaking

A proposed rule on fixed-combination OTC products derived from natural sources, including animal and botanical raw materials, could be issued by FDA as early as July, according to the agency's "unified agenda" published in the Federal Register April 24.

Supplement Manufacturing Practices Survey Proposed By FDA

FDA is proposing to conduct a survey of dietary supplement companies' existing manufacturing practices for use in developing its proposed rule on industry-wide GMP standards, the agency says in an Oct. 6 Federal Register notice.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS133108

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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