FDA 483 OBSERVATION · #681 OF 1,000 MOST-CITED
Risk-based approach not applied to QMS processes
FDA cited this observation 25 times across 25 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
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been applied.
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been applied.
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been applied.
A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
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.