FDA 483 OBSERVATION · #119 OF 1,000 MOST-CITED
Maintenance of processing and production records
FDA cited this observation 192 times across 170 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
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing records showing adherence to the scheduled process.
You did not maintain processing records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to the scheduled process.
You did not maintain processing and production records showing adherence to 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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