OAI, VAI and NAI: FDA inspection classifications, explained
The free guide, narrated: what FDA’s three inspection classifications mean, why Official Action Indicated is the most serious one FDA assigns, and what usually follows an OAI.
Transcript
FDA inspection classifications, explained.
Official Action Indicated, or OAI, is the most serious inspection classification FDA assigns.
Every FDA inspection is classified after it closes as No Action Indicated, Voluntary Action Indicated, or Official Action Indicated. The classification is FDA's summary judgment of what the inspection found, and whether the agency intends to act on it.
No Action Indicated: no objectionable conditions or practices were found, or those found do not justify further action. In some cases, minor issues may have been pointed out, but remediated to the satisfaction of the FDA prior to the close of the inspection.
Voluntary Action Indicated: objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action; correction is left to the clinical investigator. VAI is a wide band: it covers a documentation gap, and it covers a near-miss serious problem, which is why the findings behind a VAI matter more than the label.
Official Action Indicated: objectionable conditions were found that FDA considers significant enough that correction cannot be left to the clinical investigator, and regulatory or administrative action is indicated. Often it leads eventually to a warning letter.
The inspector does not classify the inspection. The inspector writes an establishment inspection report and, where warranted, issues a Form FDA 483 at the close of the visit.
The reviewing center evaluates the report, the 483 and any response the clinical investigator sent, and assigns the final classification.
That review takes time: an inspection is classified weeks to months after it closes, and a classification can be revised after the clinical investigator's response is considered.
How often does OAI happen? Rarely, as a share of inspections: roughly one inspection in thirty is classified OAI, about a third are VAI, and the rest NAI.
What follows an OAI? For a clinical investigator, usually one or more of these.
A warning letter: FDA's advisory letter setting out the violations and requesting a written response, normally within 15 working days.
Disqualification proceedings, which are rare even among OAI inspections.
And scrutiny of the data. FDA may examine the data the clinical investigator contributed to any pending application, and may decide not to rely on some or all of it, which is where a clinical investigator's OAI becomes the sponsor's problem.
When you are selecting a site, an OAI on a candidate clinical investigator's record is a read-the-findings situation, not a checkbox: what was cited, how long ago, whether it escalated, and whether the site's responses and corrective action plans addressed it.
A VAI is the classification where the findings matter most, because the band is so wide. And a history of NAI inspections is a positive fact worth recording, because it is a different answer from never inspected.
The whole guide is free to read, with no account, at clinicalprecedent.com.