FDA 483 OBSERVATION · #918 OF 1,000 MOST-CITED
Report of violation of the Act (see 803.52(e)(9))
FDA cited this observation 15 times across 15 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 violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
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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