FDA 483 OBSERVATION · #934 OF 1,000 MOST-CITED
Time to report - 10 days
FDA cited this observation 15 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
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
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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