Ever wonder what happens when the FDA finds issues during an inspection? That’s where FDA Form 483 comes into play.
When is it Issued?
FDA Form 483 is handed over to a company's management after an inspection if the FDA investigator spots conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act. It’s a clear list of potential violations that could lead to products being contaminated or harmful.
Purpose of FDA Form 483
The form is essentially a heads-up to management about these objectionable conditions. It’s not the final word on violations but a prompt to take corrective actions quickly.
Is it a complete list?
Nope. FDA Form 483 is not an exhaustive list of every possible deviation. It only includes what the investigator observed during the inspection, so there might be other issues hidden/undiscovered that aren't mentioned. Firms are responsible to address the cited + non-cited observations.
How is it shared?
At the end of the inspection, the FDA Form 483 is reviewed with management. Each observation is discussed to ensure the company knows what the issues are and what needs fixing.
What Happens Next?
The FDA Form 483 doesn’t mean the company is officially in violation. The agency will review the form alongside other reports and evidence to decide if further action is needed to protect public health.
Related:
