Lexology November 21, 2023
Receiving a Warning Letter from FDA can seem daunting for any company regulated by FDA, including those offering food, drug, biologic, medical device and cosmetic products. As bad as receiving a Warning Letter may seem initially, some of the most respected companies in these industries have received Warning Letters. Ultimately, how a company responds to a Warning Letter is the difference between those who thrive and those who falter.
A Warning Letter Is Informal and Advisory
As described by FDA in the agency’s Regulatory Procedures Manual, a Warning Letter is informal and advisory. Getting a Warning Letter does not mean that FDA will take enforcement action. The Warning Letter also does not necessarily represent FDA’s final position.
In other words,...
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