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

Mylan Hit With GMP Warning Letter Despite Quality Improvement Efforts

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA issues 14-page letter citing GMP violations at three Mylan plants; company has halted production and distribution at one of the facilities.

You may also be interested in...



FDA Warning Letter Blasts Mylan’s Lax API Impurity Controls

Concerned about another possible nitrosamine scare, the US FDA has sent a warning letter to Mylan focusing on the firm’s failure to control contamination risks of its APIs and inadequate testing of reused solvents.

FDA Warning Letter Blasts Mylan’s Continued Lax Impurity Controls for APIs

Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.

Pfizer/Mylan: Pending Clash Of Quality Systems Could Determine Fate Of New Firm

After years of Mylan’s “one quality standard,” the merger with Pfizer Upjohn brings another. Which will prevail? Which should prevail?

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS078821

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