FDA 483 OBSERVATION · #514 OF 1,000 MOST-CITED
Suitability of testing methods verified
FDA cited this observation 37 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
The suitability of all testing methods is not verified under actual conditions of use.
The suitability of all testing methods is not verified under actual conditions of use.
The suitability of all testing methods is not verified under actual conditions of use.
The suitability of all testing methods is not verified under actual conditions of use.
The suitability of all testing methods is not verified under actual conditions of use.
The suitability of all testing methods is not verified under actual conditions of use.
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.
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