FDA 483 OBSERVATION · #993 OF 1,000 MOST-CITED
Labels - identify
FDA cited this observation 17 times across 16 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 identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the labels, the status of the labels and the dietary supplement that you distributed.
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the status of the labels and the dietary supplement that you distributed.
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the labels, the status of the labels and the dietary supplement that you distributed.
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the labels, the status of the labels and the dietary supplement that you distributed.
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the labels, the status of the labels and the dietary supplement that you distributed.
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the status of the labels and the dietary supplement that you distributed.
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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