FDA 483 OBSERVATION · #974 OF 1,000 MOST-CITED
Confidentiality, FDA inspection of records
FDA cited this observation 14 times across 14 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.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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