Mylan’s Glove-Integrity Warning Letter Fix Didn’t Extend to Adjacent Site
This article was originally published in The Gold Sheet
Executive Summary
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...
Pharma Pursues Generic Injectables Quality Turnaround Opportunities
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?
‘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.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.