FDA 483 OBSERVATION · #500 OF 1,000 MOST-CITED
Equipment observed, standardized, calibrated
FDA cited this observation 38 times across 38 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 compatibility testing and storage and distribution of blood and blood components is not on a regularly scheduled basis as prescribed in the SOP Manual.
Equipment used in the processing of blood and blood components is not observed, standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
Equipment used in the storage and distribution of blood and blood components is not standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
Equipment used in the processing of blood and blood components is not standardized on a regularly scheduled basis as prescribed in the SOP Manual.
Equipment used in the collection of blood and blood components is not observed and standardized on a regularly scheduled basis as prescribed in the SOP Manual.
Equipment used in the collection and processing of blood and blood components is not standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
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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