FDA 483 OBSERVATION · #155 OF 1,000 MOST-CITED
Quality Audit/Reaudit - conducted
FDA cited this observation 152 times across 147 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
Quality audits have not been performed.
Quality audits have not been performed.
Quality audits and reaudits have not been performed.
Quality audits have not been performed.
Quality audits have not been performed.
Quality audits have not been performed.
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.