FDA 483 OBSERVATION · #967 OF 1,000 MOST-CITED
Written calibration procedures
FDA cited this observation 17 times across 16 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
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules and limits for accuracy and precision.
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
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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