FDA 483 OBSERVATION · #948 OF 1,000 MOST-CITED
Components - identify lot received
FDA cited this observation 14 times across 13 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 components that you received in a manner that allows you to trace the lot to the status of the component.
You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component and the dietary supplement that you manufactured and distributed.
You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component and the dietary supplement that you manufactured and distributed.
You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the status of the component.
You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component and the dietary supplement that you manufactured and distributed.
You did not identify each unique lot within each unique shipment of components that you received in a manner that allows you to trace the lot to the supplier, the date received, the name of the component and the status of the component.
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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