FDA 483 OBSERVATION · #134 OF 1,000 MOST-CITED
SOPs not followed / documented
FDA cited this observation 173 times across 168 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
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions.
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
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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