FDA 483 OBSERVATION · #458 OF 1,000 MOST-CITED
DHR - UDI not included
FDA cited this observation 41 times across 41 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
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
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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