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

US FDA Warns Indoco To Delve Further Into Manufacturing Deviation

Data integrity and process control found lacking

Executive Summary

On paper, the tablet press was in control. In reality, it was not. What did that mean for the company? A lot more than it appeared to realize.

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.

Manufacturing Compliance Updates In Brief From US FDA And EU

Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.

‘Shadow’ Factory Challenges Continue For US FDA

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140555

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