FDA 483 OBSERVATION · #130 OF 1,923 MOST-CITED
Test methods
FDA cited this observation 232 times across 218 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.
Drug CGMP requires that the accuracy, sensitivity, specificity, and reproducibility of test methods be established and documented, and that methods used be validated under actual conditions of use; this citation means a release-critical test method is unvalidated or its validation is not documented. Where the concern is statistical acceptance sampling for devices, the parallel sits at 21 CFR 820.250.
Why FDA writes it — FDA cites this because an unvalidated test method can pass failing product or fail acceptable product — the method is the instrument that decides release, and if its performance characteristics were never demonstrated, every result it produced is in question.
- Establish and document each method’s accuracy, sensitivity, specificity, and reproducibility before using it for release decisions.
- Validate methods under actual conditions of use, and verify compendial methods are suitable for your specific product and matrix.
- Maintain the validation records and revalidate when the method, product, or equipment changes.
- Adopting a compendial or transferred method without verifying it performs on the actual product and matrix.
- Method validation was performed but the performance characteristics were never documented to the required detail.
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 4.7× the rate of the average FDA-cited firm (36.2% vs 7.8%), across 218 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
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
The accuracy of test methods have not been established.
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
The accuracy of test methods have not been established and documented.
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 →