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 Slams Centurion For Lax Data Integrity And Misplaced Priorities

Executive Summary

The US FDA lambasts Indian drug manufacturer Centurion Laboratories for misplaced priorities and data integrity failings. Workers left product residue on equipment while away for dancing festival. Out-of-specification stability testing results were torn, bagged and replaced with passing results.

You may also be interested in...



The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns

Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125391

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