In January 2019, FDA Commissioner Scott Gottlieb confirmed through a series of tweets and other statements that manufacturers should expect FDA inspections of generic drug plants to increase and become more thorough throughout the year as part of an effort to implement its "risk-based" inspection model.

According to Gottlieb, the agency has made a concerted effort to inspect every generic facility, which has allowed for "a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.”

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