FDA Inspectorate Structure

ARTICLES

How the FDA Organizes Investigators

Officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized Read More

Level I Investigators

FDA investigators advance through several stages of professional development, starting with Level I certification. However, even though the investigator that shows up at a company’s door may be conducting his or her first solo inspection, all FDA investigators have the same authority. Read More

Level II and III Investigators

After FDA investigators complete the necessary courses and on-the-job training under a senior investigator, they can move up to Level II certification in areas such as pharmaceuticals and medical devices. Read More

Advanced and National Expert Investigators

The FDA has the basic authority to conduct inspections under Section 704 of the Food, Drug & Cosmetic Act [21 U.S.C. 374]. FDA investigators are authorized to enter, and to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold or transport food, drugs, devices, tobacco products, or cosmetics. Read More