Mylan’s Glove-Integrity Warning Letter Fix Didn’t Extend to Adjacent Site
This article was originally published in The Gold Sheet
It’s a constant challenge for pharmaceutical manufacturers to ensure that quality problems identified at one site are fixed globally. In Mylan’s case, a problem with holes in gloves was resolved at one sterile manufacturing facility, but continued at another – even though it was right next door.
You may also be interested in...
Pfizer’s plan to acquire Hospira is part of a turnaround trend in which Big Pharma hopes its quality will rub off on the troubled generics injectables sector. The question is: Will it work?
BARDA’s consortium approach scrutinized as industry recovers from US Defense Production Act rated orders. Questions of sustainment fees, interruptible commercial activities explored during BioMaC Industry Day call as agency emphasizes need for proven capacity.
Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.