FDA 483 OBSERVATION · #121 OF 1,923 MOST-CITED
Design history file
FDA cited this observation 256 times across 238 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 Design History File (DHF) — the compilation of records describing the design history of a finished device — is missing, incomplete, or does not demonstrate that the design was developed in accordance with the approved design plan and the design-control requirements of §820.30.
Why FDA writes it — The DHF is the evidence that design controls were actually applied. Without it, FDA cannot confirm that inputs, outputs, reviews, verification, validation, and transfer occurred, so there is no assurance the marketed device is the one that was actually designed and validated.
- Maintain a DHF index that maps each §820.30 activity (plan, inputs, outputs, reviews, V&V, transfer, changes) to its underlying records.
- Reconcile the DHF against the approved design plan and close any activity that has no corresponding record.
- Keep the DHF current through design changes so it reflects the design as transferred to production.
- Review DHF completeness at each design review and at design transfer before commercial release.
- Design records live scattered across engineers’ folders and systems with no controlled compilation.
- Legacy or acquired products were transferred without ever assembling a compliant DHF.
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 2.1× the rate of the average FDA-cited firm (16.0% vs 7.8%), across 238 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 design history file was not established.
The design history file was not established.
The design history file does not demonstrate that the design was developed following the approved design plan.
The design history file was not established.
The design history file was not established.
The design history file was not 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 →