FDA 483 OBSERVATION · #773 OF 1,000 MOST-CITED
Laboratory equipment calibration records
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
Laboratory records do not include complete records of the periodic calibration of laboratory instruments and apparatus.
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Laboratory records do not include complete records of the periodic calibration of laboratory.
Laboratory records do not include complete records of the periodic calibration of laboratory apparatus, gauges and recording devices.
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Laboratory records do not include complete records of the periodic calibration of laboratory instruments and apparatus.
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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