FDA 483 OBSERVATION · #785 OF 1,000 MOST-CITED
Equipment calibration frequency
FDA cited this observation 20 times across 20 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
Equipment used in the storage and distribution of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Equipment used in the collection of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Equipment used in the collection, processing and storage and distribution of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Equipment used in the collection and processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Equipment used in the processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
Equipment used in the collection and processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
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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