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The FDA 483 is a form that FDA issues to companies after inspection. It contains the list of violations of FDA regulations in the facility. This FDA 483 form gives the company a chance to fix the listed issues.
An FDA 483 doesn’t always mean serious problems. Sometimes they are minor issues like improper labeling. Other times they are serious problems that could lead to contaminated products.
Some FDA 483s are publicly available on the FDA’s website and the consumer can assess those to get information about the company and its products. Other companies can also access them to avoid the same mistakes in their firms.
