FDA 483 OBSERVATION · #176 OF 1,923 MOST-CITED
Software validation for automated processes
FDA cited this observation 177 times across 163 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 is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.3× the rate of the average FDA-cited firm (9.8% vs 7.8%), across 163 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
Software used as part of the quality system has not been validated for its intended use according to an established protocol.
Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Software used as part of the quality system has not been validated for its intended use according to an established protocol.
Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
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 →