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

Executive Summary

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.

You may also be interested in...



Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card

Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.

Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card

Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.

US Warnings Show Focus On Sterility Risks From Water Systems Following OTC Drug Firm's Problems

A B. cepacia contamination recurrence led the US FDA to double down on sterility assurance of water systems in 2022, a trend likely to continue, Part 7 of our series finds. Open cleanroom contamination continued to drive warning letters as Annex 1 policy revision adds incentives to separate workers from injectable drug products with access barriers or isolators.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146285

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