FDA 483 OBSERVATION · #567 OF 1,932 MOST-CITED
Initial and continuing review
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 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 1.2× the rate of the average FDA-cited firm (9.5% vs 7.8%), 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
Failure to assure that an IRB complying with applicable regulatory requirements was responsible for the initial and continuing review and approval of a clinical study.
Failure to assure that an IRB complying with applicable regulatory requirements was responsible for the initial and continuing review and approval of a clinical study.
Failure to assure that an IRB was responsible for the initial and continuing review and approval of a clinical study.
Failure to assure that an IRB complying with applicable regulatory requirements was responsible for the initial and continuing review and approval of a clinical study.
Failure to assure that an IRB was responsible for the initial and continuing review and approval of a clinical study.
Failure to assure that an IRB complying with applicable regulatory requirements was responsible for the initial and continuing review and approval of a clinical study.
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 →