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 Inspections Triggered More Pharmacy Recalls in 2015

This article was originally published in The Gold Sheet

Executive Summary

Agency forces pharmacies to acknowledge they haven't been assuring the sterility of the injectable drugs they compound, spurring recalls and perhaps hope and change for their quality systems.

You may also be interested in...



NECC Crisis Festered in Ambiguity That Reigns Over Compounding

As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.

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?

CMC And GMP Updates In Brief: Continuous Manufacturing, Accelerated CMC Reviews

ICH  general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS000979

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