Responding to FDA Warning Letters: Why a Methodical Approach Helps
Blog | August 19th, 2022

Responding to FDA Warning Letters: Why a Methodical Approach Helps

Earlier this year, the Food and Drug Administration (FDA) decided to bring greater alignment between its medical device Quality System Regulation (QSR) and best practices stipulated in the ISO 13485 standard.

While this rule was first proposed in May 2018, it has now become a requirement and quality leaders are certainly happy about it. This alignment and harmonization by the FDA make global compliance easier overall– thanks to the greater correlation between compliance rules in various markets including the EU, Australia, and Japan.

FDA issues warning letters when products do not comply with certain statutory requirements. Upon receiving a warning letter from the FDA (which explains the violation with clarity), a manufacturer must outline the response plan and provide a rough timeline to complete a CAPA process, implement both corrective and preventive actions and submit relevant documentation to the FDA.

Quality and regulatory affairs (RA) leaders know that an FDA warning must be addressed with agility and effectiveness – the problem that caused the violation must be addressed, relevant documentation must be submitted back to the FDA and similar issues must be avoided in the future. This requires deep collaboration between multiple stakeholders and a data-driven process to arrive at what caused the violation.

All of this is often documented in the CAPA report, which also needs to be submitted to the FDA.

What are the Essential Elements of the CAPA Report to be Submitted to the FDA?

A CAPA report is the documentation of the actions taken to address the issue by gathering information, improving the QMS process, and implementing action plans with agility.

The document must be clear enough for the FDA reviewer to understand what specific actions have been taken.

  • Detection and determination of the issue
  • Defining the root cause of the issue
  • Implementation of corrective actions and status of the same
  • Proof of the effectiveness of fixes done
  • Monitoring and documenting the CAPA in your EQMS platform

Responding to FDA Warning Letters: A Step-by-Step Guide

Let’s discuss some of the key steps needed in addressing an FDA warning letter:

Step #1: Review the Warning Letter Thoroughly
After receiving an FDA Warning Letter, you should review the letter thoroughly as it’s important to know what and why the FDA is saying, the nature of the violation, and what type of response and actions the FDA is requesting.

Step #2: Conduct an Internal Investigation
Once you review the Warning Letter, you must conduct an internal investigation under the oversight of a legal advisor. There are two very different responses that the investigation should seek including:

1. Either validate or deny the FDA’s allegations

2. Disclose the reasons for the alleged violations (if the investigation confirms the FDA’s allegations)

The company’s response plan must be decided once the internal audit and investigation is complete.

Step #3: Define an Initial Response to the FDA
This step is critical. The medical device manufacturer should work with a legal advisor to draft an appropriate written response due to the legal implications including the potential for enforcement action.

Step #4: Respond within the Deadline Indicated in the Warning Letter
The manufacturer must respond within the deadline indicated in the Warning Letter, regardless of how much information they can reveal between the receipt of the Warning Letter and the FDA’s response deadline. Otherwise, failure to adequately address the FDA’s Warning Letters completely within the deadline may result in legal action.

Step #5: Define Accurate Next Steps
Once the manufacturer provides the initial response to FDA, then they should focus on defining the next steps depending on the merit of the FDA’s allegations.

Step #6: Rectify Any Misguided Conclusions
If a manufacturer disputes the allegations in an FDA Warning Letter, it is advisable for them to try to work with the FDA instead of working against them. The manufacturer should elaborate on why the FDA’s Warning Letter is misguided in a polite and non-aggressive way so that further inquiry or enforcement activity can be prevented.

Step #7: Take Further Preventive Action
If the FDA’s conclusions are not misguided, then the manufacturer should focus on taking any further necessary action depending on the nature and scope of the issues.

Step #8: Take Internal Corrective Action
Manufacturers should take essential corrective actions to address compliance deficiencies identified in FDA Warning Letters. Thus, you can reassess and update the manufacturer’s FDA compliance program.

Step #9: Evaluate Any Possible Risk for Enforcement Action
A manufacturer’s response to a Warning Letter prevents FDA from enforcing a penalty. But this does not mean that the manufacturer is protected from the liability of correcting the deficiencies identified in the letter. The legislation on consumer protection and violations of the FDCA (Federal Food, Drug, and Cosmetic Act) can result in private civil lawsuits.

Step #10: Gather a Defence Strategy
The manufacturer must work with their legal advisor to gather a comprehensive and cohesive defense strategy if the allegations underlying an FDA Warning Letter present a risk for civil or criminal litigation. Executing a dynamic defense strategy can significantly reduce the risks involved. Additionally, FDCA and other legal infringements can create substantial liability exposure.

Automating the FDA Response and CAPA Workflow Using ComplianceQuest

With ComplianceQuest EQMS, it becomes easy for various stakeholders and departments to collaborate and respond to the FDA Warning letter. This includes automation of various processes to be completed after a warning letter has been received including internal audit and investigation, CAPA and Root Cause Analysis, submission of the FDA response and CAPA report, etc.

With CQ EQMS, quality and RA leaders are able to streamline the following:

  • Respond to a warning letter with efficiency
  • Conduct an internal review, audit and investigation
  • Manage the CAPA and RCA process with efficiency, with data at the core
  • Tracking status of action items
  • Submission of CAPA report and FDA response report
  • Collaborate with legal teams and ensure the latest documentation is available in the document management system
  • Last but not least – work towards continuous improvement of the QMS to avoid similar warning letters in the future

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