FDA 483 OBSERVATION · #871 OF 1,000 MOST-CITED
QC - required operations master manufacturing/batch records
FDA cited this observation 21 times across 18 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
Your quality control personnel did not perform required operations for the master manufacturing record, batch record and manufacturing operations.
Your quality control personnel did not perform required operations for the master manufacturing record, batch record and manufacturing operations.
Your quality control personnel did not perform required operations for the batch record.
Your quality control personnel did not perform required operations for the batch record.
Your quality control personnel did not perform required operations for the batch record.
Your quality control personnel did not perform required operations for the master manufacturing record.
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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