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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Corrections & Removals

Corrective and 

Preventive 

Actions (CAPA) 

Reports of 

Corrections 

and Removals


 

Reports of Corrections and Removals

Inspectional Objectives

1. Determine if corrections or removals of a device were initiated by the manufacturer.

2. Confirm that the firm's management has implemented the reporting requirements of 21 CFR Part 806.

3. Verify that the firm has established and continues to maintain a file for all non-reportable corrections and removals per 21 CFR Part 806.20. Also verify that the firm is complying with the other file-related requirements of 21 CFR Part 806.

 

reports of corrections and removals decision flow chart

 

Reports of Corrections and Removals

Narrative

Purpose/Importance

The Corrections and Removals (CAR) Regulation requires medical device manufacturers and importers to promptly notify FDA of any correction or removal initiated to reduce a risk to health. This early notification improves FDA's ability to quickly evaluate risks and, when appropriate, initiate corrective actions to protect the public health.

checkmark1. Determine if corrections or removals of a device were initiated by the manufacturer.

If the firm has not initiated any corrections or removals, no inspection under Reports of Corrections and Removals is necessary, proceed to the inspection of Medical Device Tracking. However, state in the EIR that Reports of Corrections and Removals were considered for inspection.

If the firm has initiated any corrections or removals, proceed to Objective 2.  

checkmark2. Confirm that the firm's management has implemented the reporting requirements of 21 CFR Part 806.

Using the sampling tables, select a number of files relating to corrections or removals that have been reported to the FDA.

Review the files and verify that the firm: (1) is submitting written correction and removal reports to the appropriate FDA District Office within 10 days of initiating the actions; and (2) has provided all the information required in the written report per 806.10.

Using the sampling tables, select a number of corrective action files in general (e.g., CAPA files). Review the files. If you identify any apparent Class I or Class II recalls that have not been reported to the appropriate FDA District Office, discuss the discrepancy with the firm. It may be necessary to list unresolved discrepancies on your FDA 483. All observations must be consistent with current FDA policies and procedures.

checkmark3. Verify that the firm has established and continues to maintain a file for all non-reportable corrections and removals per 21 CFR Part 806.20. Also verify that the firm is complying with the other file-related requirements of 21 CFR Part 806.

Using the sampling tables, select a number of files relating to non-reportable corrections or removals (806.20 files).

mailboxNOTE: Part 806 does not require firms to establish and maintain files for corrections and removals reported to the FDA. However, documentation of corrective actions is required by the Quality System Regulation (21 CFR 820.100, Corrective and Preventive Action and 21 CFR 820.198, Complaint Files).

Review the 806.20 files and verify that the records contain all the information required in 806.20. This review must include confirmation that the files are retained for the appropriate period of time (2 years beyond the expected life of the device). 

Confirm that these files also do not contain evidence of unreported (apparent) Class I or Class II recalls. Determine whether the files contain evidence of unreported (apparent) Class III voluntary recalls under 21 CFR Part 7. Also, verify that the firm is complying with the other file-related requirements of 21 CFR Part 806.

Confirm any claims for exemption from 806 as a result of a submission under either the MDR regulation or Radiological Health requirements. If you need assistance, contact the District Recall Coordinator.

If the device has been sold to another firm, verify that the 806.20 files have been transferred to the new manufacturer or importer.

If compliance with the above requirements cannot be confirmed, discuss the discrepancy with the firm. It may be necessary to list unresolved discrepancies on your FDA 483. All observations must be consistent with current FDA policies and procedures.

mailboxNOTE: If the device has been sold to a firm that is not in your District, forward an assignment request to the appropriate District Office requesting confirmation that the 806.20 files have been transferred to the new manufacturer or importer.