FDA 483 OBSERVATION · #75 OF 1,923 MOST-CITED
Lack of or inadequate DHR procedures
FDA cited this observation 343 times across 317 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 firm has not established, or has inadequately established, procedures to ensure that a Device History Record (DHR) is maintained for each batch, lot, or unit — the objective evidence that a device was actually built in conformance with the Device Master Record.
Why FDA writes it — Without a governing DHR procedure, a manufacturer cannot demonstrate that finished devices were produced per the DMR. FDA treats the missing procedure as a systemic gap: if the rule for capturing production evidence is absent, any single record’s completeness is unverifiable and traceability collapses.
- Write a DHR procedure that defines what constitutes a batch/lot/unit and requires a DHR for each, referencing the applicable DMR.
- Specify the required DHR contents per §820.184(a)–(e) and assign clear ownership for compilation and review before release.
- Train production and quality staff to the procedure and audit a sample of DHRs against it during internal audits.
- Link DHR review to the finished-device acceptance and release decision so no unit ships without a complete record.
- The quality system grew around informal shop-floor travelers that were never formalized into a controlled DHR procedure.
- Rapid product or volume scale-up outpaced documentation, so the firm relied on habit rather than a written requirement.
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 (9.5% vs 7.8%), across 317 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 device history records have not been established.
Procedures for device history records have not been adequately established.
Procedures for device history records have not been established.
Procedures for device history records have not been adequately established.
Procedures for device history records have not been adequately established.
Procedures for device history records 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 →