FDA 483 OBSERVATION · #937 OF 1,000 MOST-CITED
Quality control operations - material review, disposition
FDA cited this observation 15 times across 15 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 do not have quality control operations for a material review and disposition decision.
You do not have quality control operations for a material review and disposition decision.
You do not have quality control operations for a material review and disposition decision.
You do not have quality control operations for a material review and disposition decision.
You do not have quality control operations for a material review and disposition decision.
You do not have quality control operations for a material review and disposition decision.
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.