FDA Form 483 Observations, Warning Letter

FDA 483 Observations: We will…

  • Review your 483 observations

  • Identify Corrective Actions

  • Assist in Corrective Action Planning

  • Write your 483 Response

No medical device or IVD manufacturer wants to receive a Form 483 or Warning Letter from the US Food and Drug Administration (FDA).

The 483 is issued at the conclusion of an on-site inspection when FDA field investigators observe deficiencies in your quality system or conditions which may violate the Food, Drug & Cosmetic Act.

You must respond to the 483 within 15 business days and identify your specific course of action to correct the findings. A detailed response for each item addressed in the 483 is expected. The quality and promptness of your response to this letter are extremely important.

If the response to the 483 is deemed insufficient, an FDA Warning Letter may be issued to your firm. If not handled properly, business interruptions may occur and your customers, sales, and profits may be affected!

We have been writing audit responses for over 20 years for Fortune 100 companies and others, and have assisted in the avoidance of several warning letters. Using our experience, we can assist you in preparing an effective response to FDA and we can perform remedial actions 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.
  • “Roll up our sleeves” and implement “Corrective Actions” in response to FDA Form 483 and subsequent CAPAs.

Vision28 has helped numerous medical device and IVD companies formulate responses to FDA 483 and Warning Letters, and worked directly implementing corrective actions and providing evidence of effectiveness.