FDA 483 OBSERVATION · #73 OF 1,923 MOST-CITED
Calibration, Inspection, etc. Procedures Lack of or Inadequ
FDA cited this observation 348 times across 315 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.
The firm has not established, or has inadequately established, procedures to ensure that inspection, measuring, and test equipment is suitable for its intended purpose and is routinely calibrated, inspected, checked, and maintained — including handling, preservation, and storage so accuracy and fitness for use are preserved.
Why FDA writes it — Every acceptance and release decision rests on measurement equipment reading true. If the governing calibration and maintenance procedure is missing, FDA cannot trust any pass/fail result the firm has recorded, and out-of-tolerance instruments could have released nonconforming devices without anyone knowing.
- Establish procedures covering calibration, inspection, checking, and maintenance of all inspection, measuring, and test equipment.
- Maintain an equipment inventory with assigned calibration intervals traceable to national or international standards where they exist.
- Define documented calibration limits and the action taken when equipment is found out of tolerance, including impact assessment on prior results.
- Control handling, preservation, and storage so accuracy is not degraded between uses.
- Equipment is added to the floor without being entered into the calibration program.
- The procedure omits out-of-tolerance handling, so no one assesses product accepted on a failed instrument.
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 1.5× the rate of the average FDA-cited firm (11.8% vs 7.8%), across 315 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
Procedures to ensure equipment is routinely calibrated have not been adequately established.
Procedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Procedures to ensure equipment is routinely calibrated have not been adequately established.
Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
Procedures to ensure equipment is routinely calibrated and inspected have not been established.
Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
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 →