FDA 483 OBSERVATION · #730 OF 1,000 MOST-CITED
Person performing, test results, interpretation
FDA cited this observation 22 times across 22 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
Records fail to identify the person performing the work so as to provide a complete history of the work performed.
Records fail to show test results so as to provide a complete history of the work performed.
Records fail to identify the person performing the work and be as detailed as necessary so as to provide a complete history of the work performed.
Records fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
Records fail to identify the person performing the work, include dates of the various entries and be as detailed as necessary so as to provide a complete history of the work performed.
Records fail to be as detailed as necessary so as to provide a complete history of the work performed.
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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