By: Bruce McDuffee
03/15/2011
If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (FDA).
According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, such as when a drug is being manufactured for the first time, if there have been previous problems validating a similar process, if production of a product or a new process is substantially different from past operations, or when a process is particularly complex.
The FDA has put out the word that it is ramping up enforcement efforts, so why not be prepared?
What you should expect
Will the inspector just show up at the back door and sneak in for a quick look, or is it a more formal process? You may or may not receive notice; inspectors have been known to show up unannounced and there is no requirement that they provide you notice. But they are not allowed to sneak in the back door for a quick look around the factory.