FDA 483 OBSERVATION · #341 OF 1,000 MOST-CITED
Establishment of calibration procedures
FDA cited this observation 61 times across 60 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
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed and deficiently written or followed.
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
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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