FDA 483 OBSERVATION · #120 OF 1,923 MOST-CITED
DHR content
FDA cited this observation 256 times across 243 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 specific Device History Record is missing one or more of the contents required by §820.184(a)–(e): the manufacturing dates, quantity manufactured, quantity released for distribution, acceptance records showing the device was built per the DMR, the primary identification label and labeling used, and any device identification and control numbers.
Why FDA writes it — An incomplete DHR breaks the evidentiary chain that a specific lot met specification and was properly released. FDA protects against distributing units whose acceptance status, quantity reconciliation, or labeling cannot be reconstructed — a recall or complaint investigation would then have no factual basis.
- Use a DHR template that enumerates every §820.184(a)–(e) element so a missing field is visible before release.
- Reconcile quantity manufactured against quantity released and account for any difference (scrap, samples, rejects).
- Capture the actual primary identification label and labeling, plus control/identification numbers, in each record.
- Perform a documented DHR completeness review as a release gate, signed by the quality unit.
- Records are compiled from multiple stations and one contributing form is routinely skipped or filed late.
- The template predates a labeling or numbering change, so newer required fields were never added.
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× the rate of the average FDA-cited firm (7.8% vs 7.8%), across 243 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 device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
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 →