FDA 483 OBSERVATION · #394 OF 1,932 MOST-CITED
Consent form not approved/signed/dated
FDA cited this observation 66 times across 66 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× the rate of the average FDA-cited firm (7.6% vs 7.8%), across 66 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
Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB.
Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB.
Informed consent was not properly documented in that the written informed consent used in the study was not dated by the subject or the subject's legally authorized representative at the time of consent.
Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB and was not dated by the subject or the subject's legally authorized representative at the time of consent.
Informed consent was not properly documented in that the written informed consent used in the study was not dated by the subject or the subject's legally authorized representative at the time of consent.
Informed consent was not properly documented in that the written informed consent used in the study was not signed by the subject or the subject's legally authorized representative at the time of consent and was not dated by the subject or the subject's legally authorized representative at the time of consent.
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 →