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Some Pointers From The US FDA On How To Conduct Better Out-Of-Spec Investigations

For Starters, Re-Read The 2006 OOS Guidance

 
• By Joanne S. Eglovitch

Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.  

Businessman holding bow and arrow confused by multiple bulls eye target vector - Vector
FDA Says Industry Not Hitting The Mark In OOS Investigations • Source: Shutterstock

The US Food and Drug Administration is still reporting a trend of poor out-of-specification investigations in Form 483 reports and warning letters that the agency is anxious to resolve, an FDA official said.

Despite a guidance document that has been on the books for 13 years for dealing with such investigations, industry is...

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