FDA 483 OBSERVATION · #391 OF 1,000 MOST-CITED
Definition very small importer
FDA cited this observation 50 times across 46 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 chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer before initially importing a food as a very small importer.
You chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer before initially importing a food as a very small importer and annually each year after importing food as a very small importer.
You chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer annually each year after importing food as a very small importer.
You chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer before initially importing a food as a very small importer.
You chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer.
You chose to comply with the requirements for a very small importer, but you did not document that you meet the definition of a very small importer before initially importing a food as a very small importer.
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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