FDA 483 OBSERVATION · #921 OF 1,000 MOST-CITED
Critical factors not stated
FDA cited this observation 19 times across 19 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
A critical factor that may affect the scheduled process was not specified in the scheduled process.
A critical factor that may affect the scheduled process was not specified in the scheduled process.
A critical factor that may affect the scheduled process was not specified in the scheduled process.
A critical factor that may affect the scheduled process was not specified in the scheduled process.
A critical factor that may affect the scheduled process was not specified in the scheduled process.
A critical factor that may affect the scheduled process was not specified in the scheduled process.
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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