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


Manufacturing Compliance Updates In Brief From US FDA And EU

Executive Summary

Data integrity problems reemerged as a theme in seven recent drug GMP warning letters the US FDA sent to drug and active ingredient manufacturers at sites in South Korea, Australia, Taiwan, China, Ireland and France. Investigators also are seeing problems with inadequate testing of components and inattention to investigating batch failure. FDA issued a Form 483 report to Glenmark in India for inadequate cross-contamination controls, in the EU, the Spanish Agency of Medicines and Medical Devices withdrew one Spanish drug maker’s GMP certificate for multiple GMP violations.

You may also be interested in...

FDA Warns Glenmark Over Temperature Excursions, Gritty Topicals

Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.

The Next New Thing In FDA Inspections: Poor Root Cause Investigations

Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.

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

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.

Related Content


Latest Headlines
See All



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