FDA 483 OBSERVATION · #298 OF 1,000 MOST-CITED
Minutes of IRB meetings
FDA cited this observation 72 times across 69 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.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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