Search FDA 483 letters

It is time for it to be easy to search FDA 483s letters.

What is and FDA form 483?

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.

What happens after a pharmaceutical company receives a FDA form 483?

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.

Is the order of the observations on the FDA 483 form important?

Yes, the observations are listed on a Form 483 in order of significance by the investigator. The format of any single observation begins with a statement based in a citation of law, regulation or Act and is followed by a statement of specific conditions observed during the inspection.

What are the observations that can be listed on and FDA form 483?

See the list below for the top 100 sited FDA form 483 drug inspection observations for 2019. They are listed by the citation ID, then a short observation description and then the format for the long observation description