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

GMP-Deficient Supplement Own-Labeler Also Dabbles In OTC Drug Sales

This article was originally published in The Rose Sheet

Executive Summary

Mega-Pro Nutrition is one of two own-labelers, along with Vicare International Inc., warned on GMP violations in warning letters FDA published Sept. 26. A third supplement firm, Newton-Everett, was warned about making extensive drug claims for its products, including in social media posts.

You may also be interested in...



FSMA Re-inspection Fees MIA As Waiver Guidance Remains AWOL

FDA will bill supplement and conventional food product firms $248 per hour for re-inspections in the US and $285 per hour outside the country in fiscal 2018, but as it has since Congress passed FSMA, the agency will not collect re-inspection and mandatory recall fees.

NPLEx Brings A ‘Quiet’ Year On State PSE Legislation – CHPA

CHPA President and CEO Scott Melville says 2015 is the “quietest” in five years for state legislation on the sale of pseudoephedrine, a testament to NPLEx. Bills for Rx-only PSE sales introduced in four states this year failed.

Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS121223

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