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The Quality Lowdown: Rewarding Your Best Quality Critics

 
• By Bowman Cox

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

Although it may be a common career path to advise the pharmaceutical industry on quality as a consultant or employee after providing free advice for years as a US Food and Drug Administration enforcement official, it’s still rather striking when such an official pens a blistering warning letter, then a year later joins the company.

But that’s what happened with Lupin Limited, whose new employee has a head start on knowing what the problems...

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