FDA 483 OBSERVATION · #1540 OF 1,916 MOST-CITED
IRB approvals/disapprovals - general
FDA cited this observation 7 times across 7 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.
How FDA worded it — real examples
The IRB has not promptly notified in writing the investigator when the IRB has approved proposed research activity.
The IRB has not promptly notified in writing the institution when the IRB has approved, disapproved and required modifications to secure IRB approval of proposed research activity.
The IRB has not promptly notified in writing the investigator when the IRB has disapproved and required modifications to secure IRB approval of proposed research activity.
The IRB has not promptly notified in writing the investigator when the IRB has approved proposed research activity.
The IRB has not promptly notified in writing the investigator when the IRB has approved, disapproved and required modifications to secure IRB approval of proposed research activity.
The IRB has not promptly notified in writing the investigator and the institution when the IRB has approved and required modifications to secure IRB approval of proposed research activity.
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 →