FDA 483 OBSERVATION · #405 OF 1,000 MOST-CITED
Review and evaluation for investigation
FDA cited this observation 49 times across 47 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
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
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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