A FDA Form 483 is known as a “Notice of Inspectional Observations.” The FDA field inspector will issue a 483 letter after he/she completes an on-site inspection. The FDA 483 will officially list the deficiencies with your quality system.
It is important to note that the observations in a FDA 483 are based on the FDA inspector’s interpretation of the regulations as they relate to your operation. According the the FDA “There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.” This is why outside help can be critical for responding to a FDA 483 form letter.
Your organization must respond to the FDA 483 letter promptly and you need to identify your course of action to correct the findings. A detailed response for each item in the 483 will also be required.
Learn more about how to handle your FDA Compliance Issues:
- How To Be Ready For A FDA Inspection
- How To Understand Your FDA 483 Observations
- How To Respond To Your FDA 483
- FDA 483 Response Sample Format
- Understanding FDA Compliance
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.