Glossary
Specificity
The ability to assess the analyte accurately in the presence of other components such as impurities, degradants, and matrix.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The proposed sanitize-able metal tool for trash handling lacks specificity and does not mitigate immediate contamination risks during aseptic operation.
FDA · FDA Warning Letter · 2026-03-17 -
The accuracy, sensitivity and specificity of test methods have not been documented.
FDA · FDA 483 · 2019-04-08 -
The accuracy, specificity and reproducibility of test methods have not been established and documented.
FDA · FDA 483 · 2020-02-24
