FDA 483 OBSERVATION · #77 OF 1,923 MOST-CITED
Design control - no procedures
FDA cited this observation 339 times across 316 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.
A device manufacturer lacked established design-control procedures — the documented process for planning, controlling, and verifying/validating device design was absent for a device that requires design controls.
Why FDA writes it — Design controls are how a device is made safe and effective before it is ever produced. Without them, design inputs, verification, validation, and design changes go unmanaged, so defects and unmet user needs get built into the product — which is why FDA treats a missing design-control system as a foundational failure.
- Establish and maintain procedures to control the design of the device, including design planning, inputs, outputs, review, verification, validation, transfer, and changes.
- Define and document design inputs (user needs, intended use, requirements) as the basis for the design.
- Verify that outputs meet inputs and validate that the device meets user needs and intended uses.
- Maintain a design history file demonstrating the design was developed per the plan and procedures.
- Treating a device as exempt from design controls when it is not, so no procedures were established.
- Design performed informally by engineering without a controlled, documented process.
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 2.2× the rate of the average FDA-cited firm (17.4% vs 7.8%), across 316 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 for design control have not been established.
Procedures for design control have not been established.
Procedures for design control have not been established.
Procedures for design control have not been established.
Procedures for design control have not been established.
Procedures for design control have not been 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 →