FDA 483 OBSERVATION · #873 OF 1,932 MOST-CITED
Equipment calibration frequency
FDA cited this observation 22 times across 22 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.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
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. Open the 483 observation explorer →