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The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

 
• By Bowman Cox

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

The Quality Lowdown

New drug good manufacturing practice warning letters trickled onto the US Food and Drug Administration’s web site even as the agency further extended a year-end inspection hiatus due to a resurgent pandemic that could lead warnings to again subside.

One warning letter dove into a problem with improperly invalidated out-of-specification findings. Another relied on a remote records review to find unacceptable gaps in release and stability testing and cleaning validation for production of an unapproved acne medicine

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