FDA 483 OBSERVATION · #553 OF 1,000 MOST-CITED
Component - certificate of analysis
FDA cited this observation 43 times across 40 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2.9× the rate of the average FDA-cited firm (22.5% vs 7.7%), across 40 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
The certificate of analysis for a component does not include a description of the test or examination method(s) used.
The certificate of analysis for a component does not include a description of the test or examination method(s) used, limits of the test or examination and actual results of the tests or examinations.
The certificate of analysis for a component does not include a description of the test or examination method(s) used, limits of the test or examination and actual results of the tests or examinations.
The certificate of analysis for a component does not include a description of the test or examination method(s) used and actual results of the tests or examinations.
The certificate of analysis for a component does not include a description of the test or examination method(s) used and limits of the test or examination.
The certificate of analysis for a component does not include a description of the test or examination method(s) used, limits of the test or examination and actual results of the tests or examinations.
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.