FDA 483 Citations for Device History Records Under 21 CFR 820.184

23 hours ago

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Device history records (DHRs) drew three separate observations on system-generated Form FDA 483s in fiscal year 2025:

"Procedures for device history records have not been [adequately] established," 820.184, 34 times
"The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820]," 820.184, 30 times
"A device history record has not been [adequately] maintained," 820.184, 24 times

Together that is 88 citations. The DHR is the evidence that each lot or unit was built and accepted as designed. When it is incomplete, FDA cannot tell whether the devices you shipped meet their specifications, and neither can you.

What the citations mean

Examples written after "Specifically" usually describe:

No procedure describing what a DHR contains or who reviews it
Missing manufacturing dates, quantities or quantities released for distribution
Missing acceptance records, such as in-process or final inspection results
No primary identification label or labeling record for the lot
Blank fields, unexplained corrections or entries made long after the work
Steps performed out of order or with equipment that is not identified
Product released before the DHR was reviewed
DHRs that do not match the current device master record revision

What 21 CFR 820.184 required

Under the Quality System Regulation, each manufacturer had to maintain device history records and establish procedures to ensure that DHRs for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of Part 820. The DHR had to include, or refer to the location of:

The dates of manufacture
The quantity manufactured
The quantity released for distribution
The acceptance records which demonstrate the device is manufactured in accordance with the DMR
The primary identification label and labeling used for each production unit
Any unique device identifier or universal product code, and any other device identification and control numbers used

What changed under QMSR

Under QMSR, in effect since February 2, 2026, the term "device history record" is no longer used in the regulation. The requirements come from ISO 13485:2016:

Clause 7.5.1, Control of production and service provision, requires the organization to maintain a record for each medical device or batch that provides traceability to the extent specified in clause 7.5.8 and identifies the amount manufactured and amount approved for distribution. The record must be verified and approved.
Clause 7.5.8 and 7.5.9 cover identification and traceability.
Clause 8.2.6, Monitoring and measurement of product, requires evidence of conformity with acceptance criteria, and records must identify the person authorizing release.
Clause 4.2.5, Control of records, requires records to remain legible, readily identifiable and retrievable, with changes kept identifiable.

QMSR section 820.35 adds FDA-specific record requirements on top of clause 4.2.5, including documenting the unique device identifier or universal product code for each device or batch. Many manufacturers still call these batch records DHRs, and that is fine. What matters is that each record shows what was built, how it was accepted and who released it.

How to respond to the 483

FDA generally considers responses received within 15 business days of the close of the inspection before deciding on further action.

Assess the records cited and the product they cover

For each DHR cited, determine what is missing and whether the gap means the product might not conform. Where evidence of acceptance is missing, use other records, retained samples or testing to show conformity, or treat the product as nonconforming. If nonconforming devices were distributed, evaluate whether a correction or removal is needed.

Review a wider sample

Review DHRs for a defined period across product lines. Report how many were reviewed, how many had gaps, and what kind.

Fix the record and the review

A DHR or batch record procedure that lists required contents
A batch record form generated from the current DMR revision
Good documentation practices: entries made at the time of the activity, no blank fields, single-line corrections that are initialed, dated and explained
A documented DHR review before release, with a checklist and a reviewer independent of the operator
Release blocked until review is complete

Train and verify

Train operators and reviewers on documentation practices and the review checklist. Audit released records for several months.

What a compliant DHR procedure contains

Scope and responsibilities
Required contents, including dates, quantities, acceptance records, labeling and UDI
How the batch record is generated from the DMR
Documentation practices and corrections
In-process and final review before release
Handling of deviations and nonconformances in the record
Retention and retrieval

Common mistakes in DHR responses

Filling in missing entries after the fact, which creates a new problem
Correcting the cited records but not reviewing others
Making review a signature without a checklist
Allowing release before the record is complete
Fixing paper forms but not electronic manufacturing records

Example: how one response section might read

This illustrates structure only; your response must describe your own facts.

Observation 4: The device history record does not demonstrate that the device was manufactured in accordance with the device master record. Specifically, the DHR for lot 24-118 has no final functional test results.

Response:

Product assessment: Retained units from lot 24-118 were tested on a stated date and met all specifications. Distribution records were reviewed, and no complaints were received for the lot.
Extended review: 120 DHRs from the last 12 months were reviewed. Nine had missing entries. Each was assessed, and no nonconforming product was identified.
Root cause: The final test record was a separate form that was not listed on the batch record, and reviewers had no checklist.
Corrective action: The batch record now lists every required attachment. A DHR review checklist was added, and the ERP system blocks release until review is signed.
Verification: Quality will audit 10 released DHRs per month for six months.

Frequently asked questions

Does QMSR still require a DHR?

QMSR does not use the term, but ISO 13485 clause 7.5.1 requires a record for each device or batch, with traceability, quantities manufactured and approved for distribution, verification and approval. In practice, the DHR continues under that requirement.

Can the DHR be electronic?

Yes. Electronic records must meet 21 CFR Part 11 where it applies, and the system must be validated for its intended use.

Can we fix a missing entry by adding it now?

Not by backdating. Document what is missing as a late entry or a deviation, explain it, and show conformity with other evidence.

How A.P. Lyon documents help

A.P. Lyon's Device History Record Procedure covers record contents, review and release. It works with the Device Master Record and Technical Documentation Procedure, the Good Documentation Practices Procedure and the Lot Inspection Procedure.

Documents are editable Word and Excel files and must be adapted to your products and organization. Your staff must be trained and the procedures followed.

Next steps

Assess the product covered by each cited record
Review a wider sample of DHRs and report the results
Add a DHR checklist and block release until review is done
Respond within 15 business days with dates for each action

To build a complete set of procedures at a volume discount, use Build Your QMS. For help with a 483 response, see A.P. Lyon consulting services.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.