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10: FDA Enforcement

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    • Identify FDA monitoring & enforcement practices
    • Understand enforcement terminologies such as misbranding, adulteration, recall, inspection, injunction, and debarment
    • Explore the civil and criminal enforcement tools and relative harshness: seizure, injunction, warning letters, 483, recall, debarment, civil penalty, criminal enforcement
    • Understand FDA recall authority
    • Apply an understanding of class I, II, & III recalls

    • 10.1: FDA Monitoring and Enforcement
      Over the last few chapters, you have explored the FDA organization, the Centers overseeing different products, and dove into some of the product areas themselves. Next, we will examine the regulations that govern this process and how the FDA inspects and enforces laws in this area to protect public health.
    • 10.2: Enforcement Terminologies
    • 10.3: Enforcement Activities
      Regulations must be enforceable to be effective, and the FDA has plenty of tools to encourage compliance. The key to the FDA is product public health and safety. Enforcement proceedings usually take place after an inspection has been deemed OAI. The inspections, through appropriate centers, can be either every two years or as indicated by an issue the FDA has been made aware of. There are two broad categories of enforcement activities; civil and criminal.
    • 10.4: Recalls
      A recall is the voluntary removal of a product by a manufacturer or at the request of the FDA. Recalls are almost always voluntary. The FDA can only issue a recall when they have the mandated power to do so. The FDA cannot recall a drug, or biologic, but can recall a medical device, some cosmetics, and food. When they do have recall authority, they can only do so when there is a substantial public health and safety risk.

    This page titled 10: FDA Enforcement is shared under a CC BY license and was authored, remixed, and/or curated by Jack O'Grady.

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