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

US FDA Warns Foreign Manufacturers Of OTC Analgesics For Monograph Non-Compliance

Executive Summary

Malaysia-based Furley Bioextracts and Honduras-based Laboratorio Pharma International receive warning letters from the US FDA following import alerts in May and June for marketing products as OTC analgesic drugs without complying with controlling monograph conditions.

You may also be interested in...



OTC Topicals After Bite, Itch Eraser Are Irritants To US FDA Monograph, GMP Regulations

Adventure Ready Brands is the second small firm warned recently by FDA about manufacturing and marketing products labeled as nonprescription drugs but noncompliant with relevant OTC drug monographs and about GMP violations.

OTC Ear Care Firm Eosera Gets Earful From US FDA On Pain And Itch Remedies, GMP Compliance

Eosera has removed its Ear Pain MD and Ear Itch MD products from e-commerce pages on its website following FDA's warning letter. The warning identifying the pain and itch products as unapproved new drugs also states that a January inspection of the firm’s facility found GMP violations. 

Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States

Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS151790

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