FDA 483 OBSERVATION · #1163 OF 1,932 MOST-CITED
Procedures, identification of those which were experimental
FDA cited this observation 13 times across 13 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
The informed consent document did not contain a description of the procedures to be followed and identification of any procedures which were experimental.
The informed consent document did not contain identification of any procedures which were experimental.
The informed consent document did not contain a description of the procedures to be followed and identification of any procedures which were experimental.
The informed consent document did not contain a description of the procedures to be followed.
The informed consent document did not contain identification of any procedures which were experimental.
The informed consent document did not contain a description of the procedures to be followed.
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 →