Glossary
Range
The interval between the upper and lower amounts over which an analytical procedure shows suitable precision, accuracy, and linearity.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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As such, you have not provided scientific evidence to demonstrate that the wide ranges of airflow velocities generated by your HEPA filters do not adversely impact the airflow patterns inside your ISO 5 classified critical areas.
FDA · FDA Warning Letter · 2024-10-22 -
Laboratory equipment used for analytical testing was used outside ofthe calibrated range.
FDA · FDA 483 · 2017-05-11 -
Process Parameters (PPs) are not adequately controlled within established ranges iDCb><4> DS manufacturing process.
FDA · FDA 483 · 2026-04-24
