Pink Sheet is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Sandoz GMP Warning Letter: Is The Problem Documentation, Or Leadership?

This article was originally published in The Pink Sheet Daily

Executive Summary

Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency’s warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages.


Related Content

Novartis Turns To OTC Co-Packers As Lincoln Plant Lags
Novartis Turns To OTC Co-Packers As Lincoln Plant Lags
Sanofi GMP Problems Require Top-level Sit-down With FDA, But Product Impact Limited So Far
APP Pharmaceuticals, Praised For Easing Drug Shortages, Gets Manufacturing Warning Letter
Managing The World’s First Blockbuster Generic: An Interview With Sandoz’s George
Business News, In Brief
FDA Stops Short Of Opiates Recall After Product Mix-Up At Novartis Plant
Drug Shortage Bills Likely Drivers Of PDUFA Add-ons
GMP Warning To Sandoz Questions Continued Lot Release; Will FDA Block It?


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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