FDA 483 OBSERVATION · #94 OF 1,923 MOST-CITED
Design Validation - Risk analysis not performed/inadequate
FDA cited this observation 304 times across 280 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.
Design validation did not include adequate risk analysis (or none was performed), so the device design was not evaluated for the hazards and risks it could present in actual use.
Why FDA writes it — Design validation must confirm the device is safe for its intended use, and risk analysis is how safety is demonstrated. Omitting or under-doing risk analysis means hazards go unidentified and uncontrolled in the design — a direct patient-safety gap FDA scrutinizes closely.
- Include risk analysis, where appropriate, as part of design validation.
- Identify hazards and hazardous situations across intended use and foreseeable misuse, and evaluate and control the associated risks (aligned with ISO 14971).
- Validate on production or equivalent units under actual or simulated use conditions.
- Document residual risk and the overall benefit-risk conclusion, and update the risk file on design changes.
- Risk analysis treated as a separate paperwork exercise, not integrated into design validation.
- Analysis limited to component failures, missing use-related and foreseeable-misuse hazards.
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 2.3× the rate of the average FDA-cited firm (17.5% vs 7.8%), across 280 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
Risk analysis is inadequate and is incomplete.
Risk analysis is inadequate.
Risk analysis is inadequate.
Risk analysis is inadequate.
Risk analysis is inadequate.
Risk analysis is inadequate.
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 →