What is Form 483?
The FDA is responsible for protecting the public by ensuring their safety and health in consumption of regulated products. For that reason, the FDA is required to inspect the facilities of manufacturers or processors of these regulated products. The form the FDA uses during these inspections if issues are found is known as the 483.
The FDA handles inspections on their terms, coming unannounced at any given time. At the end of the inspection, the inspector presents an Establishment Inspection Report (EIR), which must be analyzed by the internal Quality management team being inspected in pursuance for compliance. In some cases, violations to the Food Drug and Cosmetics Act may be noted. The team then presents a Form 483 along with the EIR.
This is not a death sentence. Quite the opposite, if you think about it. It is merely a graded test. You get … Read More