FDA 483 OBSERVATION · #504 OF 1,932 MOST-CITED
List of members
FDA cited this observation 49 times across 48 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 0.3× the rate of the average FDA-cited firm (2.1% vs 7.8%), across 48 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
A list of IRB members has not been prepared and maintained, identifying members by representative capacity and any employment or other relationship between each member and the institution.
A list of IRB members has not been maintained, identifying members by name, earned degrees, representative capacity and indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations.
A list of IRB members has not been prepared and maintained, identifying members by representative capacity and any employment or other relationship between each member and the institution.
A list of IRB members has not been maintained, identifying members by name, earned degrees, representative capacity, indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations and any employment or other relationship between each member and the institution.
A list of IRB members has not been maintained, identifying members by name, earned degrees and representative capacity.
A list of IRB members has not been maintained, identifying members by name, earned degrees, representative capacity and indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations.
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 →