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

FDA’s Teva Warning Letter Sets Agenda For Investigating, Remedying Sterility Failures

Executive Summary

FDA has published a warning letter that not only provides detailed guidance for Teva’s ongoing remediation of sterility assurance failures at a plant in Godollo, Hungary, but also suggests a game plan for any manufacturer of sterile drug products that’s seeing signs of issues with aseptic operations.

You may also be interested in...



Industry Worries FDA Will See Drug GMP Violations Captured By Security Cameras

A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.

FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics

Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.

US FDA Promises Shorter, Quicker Drug GMP Warning Letters

The US Food and Drug Administration is writing shorter drug GMP warning letters in an effort to issue them more quickly.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS119401

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