FDA 483 OBSERVATION · #890 OF 1,000 MOST-CITED
Process for production and service provision not validated
FDA cited this observation 16 times across 16 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
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not adequately validated.
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not adequately validated.
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
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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