FDA clinical research inspections, by the numbers

The FDA inspection record for clinical research, by the numbers.

Since fiscal year 2009, FDA has classified nearly twelve thousand Bioresearch Monitoring inspections in drug and biologic clinical research.

They took place at more than nine thousand facilities. The large majority were inspections of clinical investigators; the rest, of sponsors, CROs and IRBs.

In most years, FDA classified between six hundred and eight hundred of them.

The count fell in fiscal 2020 and 2021 due to travel restrictions during the pandemic, and has since recovered toward its earlier level.

The newest year is still filling in. FDA classifies an inspection weeks to months after it closes.

Each inspection receives one of three classifications.

About two in three are No Action Indicated.

About three in ten are Voluntary Action Indicated: objectionable conditions were found, and correction is left to the clinical investigator.

And about three in a hundred are Official Action Indicated, the most serious inspection classification FDA assigns.

Often it leads eventually to a warning letter.

Here is the whole record at once, ten inspections to a square.

About four thousand found objectionable conditions, and were classified VAI or OAI.

About three hundred and fifty were classified OAI.

And over the same years, FDA issued about two hundred warning letters.

Of the sites with an OAI inspection, about half later received a warning letter.

When one followed, FDA took a median of about seven and a half months to issue it. Half arrived between five and eleven months after the inspection.

For a site with a recent OAI, that is the period to ask about its responses and corrective action plans.

There's a lot more to inspection history than a warning letter.

The disqualification and debarment lists are smaller still.

The great majority of clinical investigators with a history appear on neither. Their record lives in the inspections, the findings and the warning letters.

Across these inspections, FDA cited about sixty-seven hundred findings.

At clinical investigators, two areas lead in every year: conducting the study, cited in about four of five inspections with a finding, and case histories, in about half.

Then come informed consent, and control of the investigational drug.

One more fact sits behind these numbers. FDA sends inspection findings to the clinical investigator, not typically to the sponsor.

Yet the sponsor remains ultimately responsible for the quality and integrity of the trial data.

Clinical Precedent assembles this record, so you can read it for one clinical investigator or site before you select it.

These figures, and seventeen free guides, are at clinicalprecedent.com.