Understanding FDA 483 and Warning Letters

Understanding FDA 483 and Warning Letters

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. 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.

How is that different than a FDA warning letter

Typically a 483 is first issued and can be escalated to a warning letter. 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.

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