FDA 483 OBSERVATION · #532 OF 1,000 MOST-CITED
Approval and review of procedures
FDA cited this observation 35 times across 35 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 procedures are not reviewed and approved by the quality control unit.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.