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

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

Executive Summary

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.

You may also be interested in...



Intas’ Response To Second Data Integrity Inspection Still Did Not Go Far Enough, US FDA Says

Intas – the the troubled Indian firm at the center of the cisplatin shortage – may have punished workers for their visual-inspection subterfuge, but it also should have gone after managers, the FDA asserted in a second data integrity warning letter in four months.

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148270

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