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

Fercy Warning Letter Confirms OTC Monograph Fears

This article was originally published in The Gold Sheet

Executive Summary

Drug maker in China found to exploit gap in U.S. regulatory system, exporting OTC monograph drugs without key quality controls or registration until FDA inspection led to import suspension.

You may also be interested in...



Shortcuts Pursued in Effort to Close Compendial Gaps

Officials with FDA, the U.S. Pharmacopeia and the pharmaceutical industry are looking for a quicker way to remedy a situation underscored by the 2008 heparin crisis: the need to update hundreds, perhaps thousands of the compendial standards that the U.S. Pharmacopeia developed and FDA enforces.

Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes

Draft recommendation offers path to ICH Q12 regulatory relief.

UsernamePublicRestriction

Register

PS000710

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