FDA 483 OBSERVATION · #591 OF 1,000 MOST-CITED
Continue to import, change activities
FDA cited this observation 31 times across 29 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
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not promptly determine and document whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities need to be changed.
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not determine and document whether it is appropriate to continue to import the food from the foreign supplier.
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not determine and document whether it is appropriate to continue to import the food from the foreign supplier.
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not determine and document whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities need to be changed.
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not promptly determine and document whether it is appropriate to continue to import the food from the foreign supplier.
After you determined that concerns associated with importing a food from a foreign supplier changed, you did not promptly determine and document whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities need to be changed.
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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