FDA 483 OBSERVATION · #99 OF 1,923 MOST-CITED
DHR - not or inadequately maintained
FDA cited this observation 297 times across 281 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 History Record (DHR) — the record demonstrating a device was manufactured in accordance with the DMR — was not maintained or was inadequate, so there was no evidence a specific batch/unit was made per its specifications.
Why FDA writes it — The DHR is the proof that a device was actually produced to its master record. Missing or incomplete DHRs mean the manufacturer cannot demonstrate a released device conformed to its specifications — undermining every release decision.
- Maintain a DHR for each batch, lot, or unit demonstrating manufacture per the DMR.
- Include the dates of manufacture, quantity manufactured and released, acceptance records, primary identification label and labeling, and any device identification and control numbers used.
- Complete the DHR contemporaneously as the device is produced.
- Link the DHR to the DMR it was built to.
- DHRs completed after the fact or missing acceptance records, so conformance is not demonstrable.
- No linkage between the DHR and the DMR version it was built to.
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 1.2× the rate of the average FDA-cited firm (9.3% vs 7.8%), across 281 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 history record has not been maintained.
A device history record has not been adequately maintained.
A device history record has not been maintained.
A device history record has not been maintained.
A device history record has not been adequately maintained.
A device history record has not been adequately 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 →