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What is the difference between and FDA 483 and a Warning Letter

FDA 483 Warning Letter Overview

What is and FDA form 483?
FDA form 483 is used as a written notice of deficiencies found in inspections. It is a form that is used to close out a FDA inspection.


What happens after a pharmaceutical company receives a FDA form 483?
After the inspection the pharmaceutical company must respond to any observations in the FDA inspection. After the response, the FDA will then decide next steps which can vary from accepting the response or escalating the 483 towards a warning letter.


What are FDA Warning Letters?
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.


Is a 483 worse or a warning letter?
Typically a 483 is first issued and can be escalated to a warning letter.

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