FDA 483 OBSERVATION · #965 OF 1,932 MOST-CITED
Confidentiality, FDA inspection of records
FDA cited this observation 18 times across 18 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.
How FDA worded it — real examples
There was no statement in the informed consent document that noted the possibility that the Food and Drug Administration might inspect the records.
There was no statement in the informed consent document that noted the possibility that the Food and Drug Administration might inspect the records.
There was no statement in the informed consent document that described the extent, if any, to which confidentiality of records identifying the subject would be maintained.
There was no statement in the informed consent document that noted the possibility that the Food and Drug Administration might inspect the records.
There was no statement in the informed consent document that described the extent, if any, to which confidentiality of records identifying the subject would be maintained and noted the possibility that the Food and Drug Administration might inspect the records.
There was no statement in the informed consent document that noted the possibility that the Food and Drug Administration might inspect the records.
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 →