FDA 483 OBSERVATION · #314 OF 1,932 MOST-CITED
Minutes of IRB meetings
FDA cited this observation 92 times across 85 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.5× the rate of the average FDA-cited firm (3.5% vs 7.8%), across 85 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Minutes of IRB meetings have not been prepared in sufficient detail to show actions taken by the IRB and the vote on actions, including the number of members voting for, against and abstaining.
Minutes of IRB meetings have not been maintained in sufficient detail to show the vote on actions, including the number of members voting for, against and abstaining.
Minutes of IRB meetings have not been prepared and maintained in sufficient detail to show the vote on actions, including the number of members voting for, against and abstaining.
Minutes of IRB meetings have not been prepared and maintained in sufficient detail to show attendance at the meetings and the vote on actions, including the number of members voting for, against and abstaining.
Minutes of IRB meetings have not been prepared and maintained in sufficient detail to show attendance at the meetings, actions taken by the IRB and the vote on actions, including the number of members voting for, against and abstaining.
Minutes of IRB meetings have not been prepared in sufficient detail to show attendance at the meetings and the vote on actions, including the number of members voting for, against and abstaining.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →