FDA Overview

Slide 18 of 30 

Next slide | Previous | Beginning

•Once products are on the market, FDA keeps track of how they are manufactured and responds to reports of problems or newly identified risks.

Safe manufacturing and handling.

•To ensure the safety of marketed products, FDA staff inspect domestic and foreign manufacturers, check shipments of imported products, and collect and test product samples for signs of contamination.
•We make more than 16,000 visits to facilities that handle FDA-regulated products. We also have cooperative arrangements with many state governments to help increase the number of facilities that are checked.

Monitor for new risks

•Because initial testing of products is based on a relatively small number of users, and because variations in quality can happen in manufacturing, FDA keeps careful watch on reports of adverse experiences with products after they are marketed. The agency receives more than 400,000 problem reports a year.
•If this monitoring turns up a problem that needs to be corrected, FDA can ask the manufacturer to recall the product, withdraw approval (of a drug, for example), require labeling changes, or send warnings to physicians or other health practitioners.