FDA 483 OBSERVATION · #749 OF 1,000 MOST-CITED
Failure to submit, distinct marking
FDA cited this observation 26 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
You did not submit a required product report prior to the introduction of the product into commerce.
You did not submit a required product report prior to the introduction of the product into commerce.
You did not submit a required product report prior to the introduction of the product into commerce.
You did not submit a required product report prior to the introduction of the product into commerce.
You did not submit a required product report prior to the introduction of the product into commerce.
You did not submit a required product report distinctly marked "Radiation Safety Product Report of (your name)" prior to the introduction of the product into commerce.
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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