What FDA Saw at Compounder Behind Fungal Meningitis Outbreak
This article was originally published in The Gold Sheet
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?
You may also be interested in...
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.
FDA issued 42 GMP drug warning letters in FY 2015, a 6% reduction compared to the previous year. The agency’s enforcement efforts continue to focus on compounding pharmacies and foreign manufacturing sites, while data integrity lapses continue to grow and a UK MHRA inspector said that a different mindset is needed to resolve these problems.
Microbial and particulate contamination drove drug recalls to historic levels for a fifth year in 2014, FDA recall data shows. But the data still falters in identifying the weakest links in global pharmaceutical supply chain quality.