The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main...
Warning Letter
Before you “Pull the Plug” on a struggling project-Call EMMA International
There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...
Common Causes of 483 Observations
Meeting and maintaining FDA compliance standards can be a challenge for even the most seasoned organization. Receiving...
Trends In 2020 FDA Pharma Warning Letters
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
483 vs Warning Letter: What’s The Difference?
The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but...
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