FDA 483 OBSERVATION · #453 OF 1,000 MOST-CITED
Written QA procedures established, followed
FDA cited this observation 42 times across 33 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 follow written quality assurance procedures.
You did not establish and follow written quality assurance procedures.
You did not follow written quality assurance procedures.
You did not establish written quality assurance procedures.
You did not follow written quality assurance procedures.
You did not establish and follow written quality assurance procedures.
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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