The Quality Lowdown: Rewarding Your Best Quality Critics
Lupin hires former nemesis at FDA, how Baker exposed Hisun’s ‘full investigation,’ Cetylite’s many methods for overcoming OOS results, old school inspection-driven recalls at Vitae Enim Vitae Scientific and a critique of Catalent filling line’s non-deliberate response to the pandemic.
You may also be interested in...
As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
Cleaning oversights are again allowing drug residues to collect in manufacturing equipment ductwork and contaminate drug product batches at sometimes dangerous levels, agency enforcement and compliance officials say. They share some ideas for getting such problems under control.
Lupin says it is rebuilding its reputation for quality and compliance after the US FDA awarded VAI status to a manufacturing facility in Goa that was hit by a warning letter back in 2017.