FDA 483 OBSERVATION · #66 OF 1,923 MOST-CITED
DMR - not or inadequately maintained
FDA cited this observation 371 times across 339 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 Device Master Record (DMR) — the compilation of records defining how a device is produced — was not maintained or was inadequate, so the specifications and procedures for manufacturing the device were incomplete or missing.
Why FDA writes it — The DMR is the recipe for a device: specifications, production processes, quality-assurance procedures, packaging, and labeling. An incomplete DMR means the device is made without a controlled definition of how it should be made, so consistency and conformance cannot be assured.
- Maintain a DMR for each type of device, including device specifications, production process specifications, quality-assurance procedures and acceptance criteria, packaging and labeling specifications, and installation/servicing procedures where applicable.
- Keep the DMR current through change control.
- Ensure each DMR is prepared and approved per 21 CFR 820.40 (document controls).
- Reference the DMR from the device history record so production traces back to it.
- DMR content scattered and never compiled/controlled as a defined record.
- DMR not updated when the device or process changes, so it no longer defines production.
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 1.6× the rate of the average FDA-cited firm (12.4% vs 7.8%), across 339 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
A device master record has not been adequately maintained.
A device master record has not been maintained.
A device master record has not been maintained.
A device master record has not been adequately maintained.
A device master record has not been adequately maintained.
A device master record has not been maintained.
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 →