FDA 483 OBSERVATION · #774 OF 1,932 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.
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
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. Open the 483 observation explorer →