FDA 483 Citations for Unreported Corrections and Removals Under 21 CFR Part 806

"A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA." FDA investigators cited 21 CFR 806.10(a)(1) with that wording 12 times on system-generated Form FDA 483s in fiscal year 2025.

This is a short list, but an unreported field action is one of the most serious things an investigator can find. It means FDA did not know that devices on the market had a problem serious enough for the manufacturer to act. These findings can lead to warning letters and to FDA classifying the action as a recall after the fact.

What the citation means

Examples written after "Specifically" usually describe:

• Devices retrieved from customers or relabeled in the field with no report to FDA

• Software patches pushed to installed devices to fix a safety problem, with no report

• "Customer notifications" or "technical bulletins" that were really corrections

• Field actions classed internally as stock recoveries or market withdrawals without a defensible rationale

• No record explaining why an action was not reported

• Reports submitted months after the action began

What 21 CFR Part 806 requires

Part 806 was not changed by QMSR and applies today.

Reporting (806.10). Each device manufacturer or importer must submit a written report to FDA of any correction or removal of a device initiated by the manufacturer or importer if it was initiated to reduce a risk to health posed by the device, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device which may present a risk to health. The report must be submitted within 10 working days of initiating the correction or removal, and must contain the information listed in 806.10(c), including the device and its identifiers, the event, the action taken, the number of devices affected and the consignees.

Definitions (806.2). A correction is the repair, modification, adjustment, relabeling, destruction or inspection, including patient monitoring, of a device without its physical removal from its point of use to some other location. A removal is the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction or inspection.

Exempt actions (806.1(b)). Actions such as market withdrawals, routine servicing and stock recoveries are not reportable under Part 806, as defined in 806.2. Actions already reported under another part of the regulations do not need a second report.

Records of unreported actions (806.20). For a correction or removal that is not reported, the manufacturer must keep a record that includes the information about the device and the action, and the justification for not reporting it, including any conclusions and follow-up. Records must be retained for a period of 2 years beyond the expected life of the device.

Under QMSR, ISO 13485 clause 8.3.3 also requires documented procedures for issuing advisory notices and for actions on nonconforming product detected after delivery.

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. For this observation, do not wait.

Report now

Submit the Part 806 report for the action cited as soon as possible and give the date in your response. Coordinate with your FDA recall coordinator, who may classify the action as a recall.

Review past field actions

Review every field action, customer notification, field software update and retrieval over a defined period, often three to five years. For each, decide whether it was reportable. Report any that were, and document the rationale for those that were not.

Fix the decision process

• A corrections and removals procedure with definitions from 806.2 and a decision tree

• A requirement that every field action, including software updates and notices, goes through the decision process

• A clock that starts when the action is initiated, not when regulatory affairs hears of it

• 806.20 records with documented justification for every unreported action

• Links to complaints, MDR, CAPA, health hazard evaluation and recall procedures

Train decision makers

Train regulatory, quality, service, marketing and engineering staff who can start field actions.

What a compliant corrections and removals procedure contains

• Definitions of correction, removal, market withdrawal, routine servicing and stock recovery

• Health hazard evaluation

• Reportability decision and documentation

• 10-working-day reporting and report contents

• Records of unreported actions and justification

• Recall strategy, consignee notification and effectiveness checks

• Coordination with FDA

• Links to complaint handling, MDR, CAPA and advisory notices

Common mistakes in corrections and removals responses

• Arguing about the definition instead of reporting and explaining

• Treating software updates as routine when they fix a safety issue

• Leaving no record for actions that were not reported

• Reviewing only the cited action and missing others

• Starting the 10-day clock late

Example: how one response section might read

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

Observation 1: A correction conducted to reduce a risk to health was not reported to FDA. Specifically, a firmware update correcting an alarm failure was installed on 230 monitors in the field without a report.

Response:

• Correction: A Part 806 report was submitted on a stated date, and the recall coordinator was contacted.

• Retrospective review: Twenty-seven field actions from the past five years were reviewed. Two additional actions were reportable and were reported on stated dates. Justifications were documented for the others.

• Root cause: Firmware updates were managed by engineering as product improvements and did not go through regulatory review.

• Corrective action: A corrections and removals procedure now requires a documented health hazard evaluation and reportability decision for every field action, including firmware updates.

• Training: Engineering, service and regulatory staff were trained on stated dates.

Frequently asked questions

How quickly must a correction or removal be reported?

Within 10 working days of initiating it, under 21 CFR 806.10(b).

Is every recall a Part 806 report?

Manufacturer-initiated corrections and removals that reduce a risk to health must be reported under Part 806. FDA then decides whether the action is a recall and classifies it.

What if we decide an action is not reportable?

Keep a record under 806.20 with the information about the action and the justification for not reporting it.

How A.P. Lyon documents help

A.P. Lyon's Remedial Action and Recall Procedure for ISO 13485 and FDA QMSR covers health hazard evaluation, reportability under Part 806, consignee notification and effectiveness checks. It links to the Complaint Handling Procedure and the Medical Device Reporting (MDR) Procedure.

Documents are editable Word and Excel files and must be adapted to your devices and organization. Reportability decisions remain the manufacturer's responsibility.

Next steps

• Report the cited action now

• Review past field actions and report any that were missed

• Put every field action through a documented reportability decision

• Respond within 15 business days with dates for each action

Related guides: MDR Procedure Citations and Complaint Handling Citations.

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.