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U.S. Department of Health and Human Services

About FDA

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Division of Field Investigations, Duties and Functions

  1. Serves as the Agency focal point coordinating, directing, and assisting the field and headquarters (HQ) with national and international investigative activities.
  2. Manages the Agency's international inspection program.
  3. Coordinates international regulatory activities, including international harmonization, with other FDA components and national and international governments.
  4. Develops, reviews and recommends policies and procedures (including guidance manuals and documents) for investigating and evaluating the compliance of regulated national and international industries with laws and regulations administered by the Agency.
  5. Provides technical expertise in investigative operations and manages the National Expert Program.
  6. Identifies and advocates investigational training needs at the district, regional and national levels for Agency personnel and participates in the design, implementation, and presentation of training programs.
  7. Monitors emerging issues and advancements in technology and recommends and coordinates implementation into the Agency's investigative activities.
  8. Manages and coordinates field acquisitions and utilization of major investigative equipment.