Pink Sheet 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

FDA Expects Drug GMP Warning Letter Tally To Reach 90 This Year

OTC Firms Lacking GMP Basics Seen Driving The Surge In Warnings

Executive Summary

FDA official says OTC firms that have not been inspected before and have limited to no knowledge of US GMP requirements appear to be driving the upward surge in drug GMP warning letters issued by the agency since January. One especially “scary” warning letter trend is manufacturers not testing incoming ingredient for diethylene glycol (DEG) or ethylene glycol (EG). Over the years, DEG contamination in pharmaceuticals has resulted in lethal poisoning incidents around the world.

You may also be interested in...



FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

FDA Reassures Patients Of Generic Drug Quality Amid Questions In Media Analysis

Commissioner Scott Gottlieb and CDER Director Janet Woodcock say in joint statement that patients can be confident generics are safe and effective and recent media reports misinterpreted inspection and other data when suggesting the contrary.

API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says

The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS123974

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