Enforcement in Brief
This article was originally published in The Gold Sheet
A consent decree brings Downing Labs to heel, while Pfizer JV partner Zhejiang Hisun gets a warning letter and a shortage-related reprieve on import alert. Meanwhile, Ipca is hit with a warning letter, Chan Yat Hing’s cosmetics ploy is blocked, and two Chinese firms get import alerts.
You may also be interested in...
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.
The Quality Lowdown: COVID-19's Pressures On Drug Quality
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
Enforcement Updates in Brief
Pan Drugs told FDA it would divert dirty plant’s API to India; Zhejiang Hisun reels from import alert, warning letter; Impax resolves warning letter; Polydrug and Akorn put on import alert; and TxCell outsources GMP problems away.