How to Prepare for an FDA Inspection of Reports of Corrections and Removals

The U.S. Food and Drug Administration (FDA) conducts routine and for-cause inspections to ensure medical device manufacturers comply with regulatory requirements, including those related to Reports of Corrections and Removals. Understanding the objectives of these inspections and taking proactive steps to prepare can help manufacturers maintain compliance and avoid potential enforcement actions.

Key Objectives of an FDA Inspection of Reports of Corrections and Removals

1. Determining Whether a Manufacturer Has Initiated Corrections or Removals

The first objective of an FDA inspection is to establish whether a manufacturer has initiated any corrections or removals of a device. If no such actions have been taken, the inspection in this area may be limited. However, if corrections or removals have occurred, the FDA will proceed with a deeper review.

2. Evaluating Compliance with Reporting Requirements (21 CFR Part 806)

FDA inspectors will confirm that the firm’s management has implemented reporting requirements per 21 CFR Part 806. This includes verifying that:

• The manufacturer submits written correction and removal reports to the appropriate FDA District Office within ten days of initiating the action.
• Reports contain all the required information specified in 21 CFR 806.10.

Inspectors will also check corrective action files to ensure that all reportable corrections and removals have been appropriately documented and reported.

3. Reviewing Records of Non-Reportable Corrections and Removals

Under 21 CFR Part 806.20, manufacturers must maintain records of non-reportable corrections and removals. FDA inspectors will assess whether these records:

• Contain all the necessary details, including justifications for non-reporting.
• Are retained for the required period (two years beyond the expected life of the device).
• Do not contain evidence of unreported Class I or Class II recalls.

If the firm has sold a device to another company, the FDA will confirm whether the 806.20 files have been transferred to the new manufacturer or importer.

4. Verifying Exemptions and Proper Documentation

If a firm claims exemption from 21 CFR Part 806 reporting due to submission under another regulatory requirement (such as Medical Device Reporting or Radiological Health requirements), inspectors will verify the validity of these claims and the adequacy of supporting documentation.

How to Prepare for an FDA Inspection

1. Maintain a Robust Documentation System

Ensuring all corrective and removal actions are well-documented is crucial. This includes:

• Detailed records of all corrections and removals.
• Reports submitted to the FDA, including justifications for non-reportable events.
• Supporting documents such as investigation reports, risk assessments, and communications with customers.

2. Establish and Follow Standard Operating Procedures (SOPs)

Manufacturers should have clear and comprehensive SOPs for:

• Identifying and evaluating potential corrections and removals.
• Determining whether an event is reportable under 21 CFR Part 806.
• Submitting required reports within the specified timeframe.
• Maintaining records of non-reportable actions.

It is essential that SOPs include key definitions as outlined in 21 CFR Part 806. These definitions should clearly distinguish between a “correction” and a “removal,” and explain the criteria for determining when each applies. A “correction” is defined as an action taken to fix a problem with a distributed device without physically removing it from the market, while a “removal” involves taking the device off the market to address an issue. Understanding these definitions ensures consistent application of regulatory requirements and helps avoid misclassification, which can lead to compliance risks.

In addition, SOPs should provide clear guidance on documenting risk evaluations and justifications for non-reportable actions. By defining these elements explicitly, manufacturers can ensure uniform compliance and preparedness for FDA inspections.

3. Conduct Internal Audits and Training

• Regular internal audits help identify gaps in compliance before an FDA inspection. Pro Tip ==> Click Here to Get Our Free 63-Page FDA Inspection Readiness Checklist
• Training staff on regulatory requirements and company SOPs ensures that all team members understand their roles in maintaining compliance.

4. Ensure Readiness for an On-Site Inspection

When an FDA inspection occurs, having a clear plan in place can facilitate a smooth process:

• Assign a regulatory compliance lead to coordinate the inspection.
• Organize all relevant documentation for easy access.
• Prepare personnel to answer questions about the firm’s correction and removal procedures.
• Conduct mock FDA inspections to simulate real scenarios and address potential issues.

Conclusion

FDA inspections of Reports of Corrections and Removals ensure that manufacturers are taking appropriate actions to protect public health. By understanding the objectives of these inspections and implementing a proactive compliance strategy, manufacturers can reduce regulatory risk, demonstrate a commitment to quality, and maintain FDA compliance. Keeping detailed records, adhering to regulatory timelines, and fostering a culture of compliance will ensure a smooth inspection process and minimize the likelihood of enforcement actions.