FDA 483 OBSERVATION · #67 OF 1,923 MOST-CITED
Calibration/Inspection/Checking not done
FDA cited this observation 371 times across 337 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.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Inspection, measuring, and test equipment was not calibrated, inspected, or checked as required, so the equipment used to make quality decisions was not demonstrably accurate.
Why FDA writes it — Every acceptance decision depends on measurement equipment being accurate. Uncalibrated or unchecked equipment means the measurements behind release decisions are unreliable — and, when calibration lapses, all product accepted using that equipment since the last valid calibration is in question.
- Establish and maintain procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained.
- Calibrate against standards traceable to national or international standards (or document the basis where none exist).
- Define and record calibration limits, and specify remedial action when equipment is found out of calibration — including assessing product accepted with it.
- Keep calibration records identifying the equipment, date, and person.
- Calibration schedules lapse, and out-of-calibration findings do not trigger an assessment of affected product.
- Calibration performed but not traceable to recognized standards or not recorded.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4.1× the rate of the average FDA-cited firm (32.0% vs 7.8%), across 337 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Routine calibration and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
Routine checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Routine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
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 →