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

Murder in the Clean Room

This article was originally published in The Gold Sheet

Executive Summary

When are pharmaceutical sterility assurance failures so egregious that they constitute murder?

You may also be interested in...



Drug Compounder Acquitted Of Murder In Fungal Meningitis Outbreak Case

Jury convicts Barry Cadden on racketeering and mail fraud allegations for shipping contaminated methylprednisolone acetate for spinal injection, but clears NECC's head pharmacist on all 25 counts of second degree murder in seminal case that spurred legislation enabling major US FDA crackdown on injectable drug compounding sterility assurance practices.

What FDA Saw at Compounder Behind Fungal Meningitis Outbreak

There was greenish-black and white filamentous matter in vials that had been recalled. The question confronting FDA investigators at NECC: How could it have gotten there?

‘Shadow’ Factory Challenges Continue For US FDA

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000874

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