FDA 483 OBSERVATION · #552 OF 1,000 MOST-CITED
Sponsors' general responsibilities
FDA cited this observation 43 times across 42 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.9× the rate of the average FDA-cited firm (7.1% vs 7.7%), across 42 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
For an investigational study, proper monitoring was not ensured.
For an investigational study, proper monitoring was not ensured.
For an investigational study, investigators were not provided with the information they need to conduct an investigation properly, proper monitoring was not ensured, reviewing IRBs were not promptly informed of significant new information about an investigation and FDA was not promptly informed of significant new information about an investigation.
For an investigational study, investigators were not provided with the information they need to conduct an investigation properly and proper monitoring was not ensured.
For an investigational study, proper monitoring was not ensured and IRB review and approval were not ensured.
For an investigational study, proper monitoring was not ensured.
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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