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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ers following an inspection.

To guide this process, there are standards that we follow for classification and violations must meet a certain level to be classified as OAI, or Official Action Indicated. While one publicly visible measure of FDA action, its important to understand that warning letters are not the FDAs only course of action with a manufacturer following an inspection. The FDA can also have regulatory meetings with companies; issue an untitled letter; conduct a follow-up inspection

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