On this page:
- What is a FDA Form 483 and how to respond
- How Emergo can help you recover from a FDA 483 or Warning Letter
No medical device or IVD manufacturer wants to receive a Form 483 or Warning Letter from the US Food and Drug Administration (FDA). Officially, the FDA Form 483 is referred to as "Notice of Inspectional Observations," commonly referred to simplay as a "483." The 483 is issued at the conclusion of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions which may violate the Food, Drug, or Cosmetic Act.
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.
The field inspector will submit the final 483 to his/her superiors; and, if the findings are serious enough, or if the response to the 483 is deemed insufficient, an FDA Warning Letter may be issued to your firm. A Warning Letter is the FDA’s advisory notice that you have significantly violated FDA regulations. It will identify the violation(s), and make it clear that you must correct the problems and inform FDA of your specific plans for correction of the problem, including actions to prevent it or a similar problem from re-occurring. The FDA will check back to ensure that the corrections are adequate.
Emergo can help you respond to an FDA Form 483 or Warning Letter.
Emergo can assist you in preparing an effective response to an FDA Form 483 and Warning Letter. We can provide you with direction to ensure your quality system is in full compliance with the regulations. As part of our services, we will:
- Analyze the findings of the FDA Form 483 and/or Warning Letter.
- Suggest an appropriate timeline to satisfy the FDA.
- Assist your company in charting a course of action.
- Propose "Corrective Actions" to be made to your quality system.
- Assist in implementing corrective actions in response to FDA Form 483.
- Be available to answer all questions from you or the FDA during your efforts to correct the noted deficiencies or violations.
Emergo has worked with numerous medical device and IVD companies to formulate proper responses to FDA 483 and Warning Letters.