FDA 483 Observations vs. Warning Letter

Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines for releasing a specific medical device or medication.  Adding to that, how your quality processes are going, or not going, and you have a recipe for FDA 483 observations or worse, FDA Warning letters 2021.

How do companies get to this point? What are the differences? How does a company avoid them? Read More.


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