Note: In 2015 the FDA announced plans for a major reorganization of its inspectorate. This section of the Inspection Insider website will be updated to reflect the reorganization as more details become available. To read the agency's notices about the upcoming changes, click here.
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
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
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