FDA 483 OBSERVATION · #1352 OF 1,916 MOST-CITED
Annual report
FDA cited this observation 10 times across 10 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
Failure to submit to FDA within 60 days of the anniversary date that the IND went into effect an annual report of the investigation.
Failure to submit to FDA within 60 days of the anniversary date that the IND went into effect an annual report of the investigation.
Failure to submit to FDA within 60 days of the anniversary date that the IND went into effect an annual report of the investigation.
Failure to submit to FDA an annual report of the investigation.
Failure to submit to FDA an annual report of the investigation.
Failure to submit to FDA an annual report of the investigation.
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 →