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No medical device or IVD manufacturer wants to receive a Form 483 and/or Warning Letter from the US Food and Drug Administration (FDA). Officially, the FDA Form 483 is referred to as "Notice of Inspectional Observations." The 483 is issued by the FDA field investigator after an on-site inspection and lists deficiencies in your quality system. The observations contained in every Form 483 are based on the inspector's interpretation of the regulations as they relate to your operational GMP quality system.
The field inspector will submit the finalized 483 to his/her superiors; based on the severity of the findings, an FDA Warning Letter may be issued to your firm.
You must respond to the 483 promptly and identify your course of action to correct the findings within a timeframe specified by the FDA. A detailed response for each item addressed in the 483 will also be required. The quality and promptness of your response to this letter are extremely important.
Emergo Group can assist you in preparing an effective response to an FDA Form 483. We can provide you with direction to ensure your GMP quality system is in full compliance with the regulations. As part of our services, we will:
Emergo Group has worked with numerous medical device and IVD companies to formulate proper responses to FDA 483 and Warning Letters.