FDA 483 OBSERVATION · #346 OF 1,932 MOST-CITED
Informed consent
FDA cited this observation 81 times across 81 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 1.6× the rate of the average FDA-cited firm (12.3% vs 7.8%), across 81 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 obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to conducting study-related tests.
Failure of the responsible physician to explain the risks and hazards of the procedure to the donor.
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to drug administration and conducting study-related tests.
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to conducting study-related tests.
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to drug administration and conducting study-related tests.
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to drug administration and conducting study-related tests.
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 →