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Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by

FDA Warning LetterYou’ve received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s [...] Read More

Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by

FDA Warning LettersMost life-sciences firms would agree that the best way to prepare for FDA Warning Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.

Comprehensive compliance [...] Read More

Life After An FDA Form 483

April 7th, 2014 by

FDA Form 483 Warning LetterFDA inspections don’t always end smoothly. Field agents may decide that the deficiencies they observed were significant enough to issue letters detailing outstanding issues. For firms [...] Read More