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: Sun’s Mohali Plant Dropped Ball On Worker’s Data Integrity Allegations

Executive Summary

Was backdating of GMP records part of an effort to move suspect product? FDA investigators found Sun was leaving lots of stones unturned in its effort to find out.

You may also be interested in...



The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration

Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.

Ranbaxy Whistleblower’s New Mission: How to Detect Fraud from Afar

A decade ago, Dinesh Thakur was able to perceive data integrity issues at Ranbaxy because of his unique position in the company. Today, he’s working to help pharmaceutical companies monitor their global manufacturing networks to detect such issues wherever they might occur.

Confronting Illusions of Quality in Indian Generics Manufacturing

A sharp increase in data integrity findings has raised questions about the quality of pharmaceutical manufacturing in India. What’s happening and why, who’s responsible, and how can drug makers and the regulatory agencies that watch over them put a stop to it?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146900

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