FDA 483 OBSERVATION · #997 OF 1,932 MOST-CITED
Failure to submit an IND
FDA cited this observation 17 times across 17 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 sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug.
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 →