What Is an FDA 483?

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A Form 483 is what a U.S. Food and Drug Administration inspector uses to note her findings and observations during an inspection of a business facility. An FDA representative will note the observations and use the form to list various concerns with the business owner.

What the Form Documents

After an inspection by the FDA, an inspector will mark observations on the form, particularly any perceived violations of the law in terms of manufacturing processes or for improper or unlisted additives in the product.

Some issues that arise can be fixed during the inspection before the form is completed, and the business owner and inspector may be able to come to an agreement on how they can be fixed before the issues make it onto the 483.

Responding to the Form

The FDA recommends a timely response to a 483. The response should address each issue included in the form and how it can be or has been fixed. However, response isn't an FDA requirement.

Possible Consequences

The FDA states a response is not required; however, not responding or not doing so properly can increase the risk of receiving a warning letter. This could, but not necessarily will, signal the beginning of a process that could lead to withholding future product approvals and plant shut-downs.

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