HBW Insight 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

ForMor Challenges FDA On Own-Label Supplement GMP Stance

This article was originally published in The Tan Sheet

Executive Summary

ForMor contests a warning letter from FDA stating that as an own-label distributor, the firm is subject to both packager and labeler GMP requirements. The firm says it is only a “holder” of finished products and FDA bases its warning on the GMP rule preamble, not the actual rule.

You may also be interested in...



US FDA Warns Supplement Own Labeler About Reliance On Manufacturer For Compliance

Revival Products’ GMP deficiencies concerned work and training of its quality control staff, including failing to document review and approval for release of any packaged and labeled supplement for distribution and destroying returned products without review.

In Brief

FDA loses patience with Confidence; Warning underscores interest in concussion claims; Nestle invests in ready-to-drink supplement plant; Garlic supplement makes drug claims; Skin care claims enter drug realm;; more In Brief.

FDA Holds Marketers Responsible For Manufacturers’ GMP Violations

FDA has begun holding own-label dietary supplement marketers responsible for their contract manufacturers’ violations of good manufacturing practices.

Topics

Related Companies

UsernamePublicRestriction

Register

RS124236

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