FDA 483 OBSERVATION · #683 OF 1,000 MOST-CITED
Late submission of annual safety reports
FDA cited this observation 25 times across 23 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
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
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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