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

FDA Continues Aggressive Enforcement as Drug GMP Warning Letters Mount

This article was originally published in The Gold Sheet

Executive Summary

The Obama administration’s FDA continues to deliver on its promise of swift and aggressive enforcement of drug GMP requirements that it pronounced two years ago.

You may also be interested in...



Foreign Drugmakers Now Getting More GMP Warning Letters Than U.S. Firms

For the first time, this fiscal year FDA seems to be on track to send more warning letters to foreign manufacturers of finished pharmaceuticals and APIs than their domestic counterparts.

Foreign Drugmakers Now Getting More GMP Warning Letters Than U.S. Firms

For the first time, this fiscal year FDA seems to be on track to send more warning letters to foreign manufacturers of finished pharmaceuticals and APIs than their domestic counterparts.

FDA Sending More Drug GMP Warning Letters to Foreign Sites

FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.

Related Content

UsernamePublicRestriction

Register

SC081785

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