FDA inspection search

The classification is the outcome, not the 483

Sponsors receive a Form 483 at the close of an inspection and treat it as the result. It is not. The result is the classification FDA assigns afterwards, and it lives in the Establishment Inspection Report, which you only see later and through a FOIA request.

That is what this searches. A supplier you are qualifying, a CDMO you are considering, a competitor site: the classification tells you what FDA concluded, and the FEI number joins it to any warning letter issued to the same establishment.

What being ready for one of these looks like is in the glossary, along with the pre-approval inspection that gates an application.

Frequently asked questions

What do NAI, VAI and OAI mean?

No Action Indicated means no objectionable conditions were found, or none warranting action. Voluntary Action Indicated means objectionable conditions were found but not at a level warranting formal action. Official Action Indicated means conditions warranting formal regulatory action, and it is the classification that precedes a warning letter, an import alert or withholding of pending applications.

Is the classification the same as a Form 483?

No. The Form 483 is the list of observations left at the close of the inspection. The classification is FDA's conclusion afterwards, recorded in the Establishment Inspection Report. A long 483 classified VAI is a better outcome than a short one classified OAI, and you cannot tell which you have from the 483 alone.

What is an FEI number?

The FDA Establishment Identifier, a unique number for a facility. It is the join between a site's inspection history and any warning letters issued to it.

What does 'citations posted' mean?

That FDA has published the specific regulatory citations from the inspection. It indicates observations were made, though the absence of posted citations does not mean the inspection was clean.

How current is this?

It queries FDA's Data Dashboard live, so results are as current as FDA's own dataset. Note that classifications appear after the inspection is closed, so a recent inspection may not be classified yet.

Why only drugs, devices and biologics?

FDA's dataset holds 341,046 inspections across all product types. Food and tobacco are the majority and none of it concerns a life sciences reader, so the default scope is the 122,289 inspections that do.