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: Rewarding Your Best Quality Critics

Executive Summary

Lupin hires former nemesis at FDA, how Baker exposed Hisun’s ‘full investigation,’ Cetylite’s many methods for overcoming OOS results, old school inspection-driven recalls at Vitae Enim Vitae Scientific and a critique of Catalent filling line’s non-deliberate response to the pandemic.

You may also be interested in...



Warning Letters Special Report: Where Investigations By Prescription Drug Product Firms Fell Short

Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.

The Quality Lowdown: Wishing Wished-For FDA Re-Inspections Had Gone Better?

As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.

Return Of Ductwork Cross-Contamination In Plants Flagged By US FDA Experts

Cleaning oversights are again allowing drug residues to collect in manufacturing equipment ductwork and contaminate drug product batches at sometimes dangerous levels, agency enforcement and compliance officials say. They share some ideas for getting such problems under control.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146101

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