FDA Remediation Guidance for Quality Systems

You established quality plans, hired an experienced team, built a quality management system, trained and retrained, prepared and practiced for regulatory inspections, diligently performed internal audits and made every effort to document it all.

And then it happens…

You just become aware that a recall is necessary, or an FDA inspection resulted in an unexpected outcome. Maybe it was a call from a health care provider reporting a product failure that leads to unexpected harm to a patient. Whatever difficult situation you may be facing, you need to react quickly and with integrity.

How your company reacts could mean the difference between a costly regulatory action and an effective resolution with minimal disruption to the business.

QualityHub’s quality, regulatory, compliance and technical experts know the most important aspects to consider when challenged with complex compliance or product issues. Here are five important points to consider for FDA remediation when your company is in a reactive mode.

When FDA schedules the inspection, consider getting help before and during the inspection to increase the chance of a successful outcome. While our expertise is often called upon after the inspection, we are better prepared to assist with inspection outcomes if we are involved earlier in the process.

Our team of experts includes former FDA investigators and officers who can be on-site quickly to provide both pre- and post-inspection support. During the inspection, it is important to have experienced backroom support that includes individuals with regulatory and quality expertise.

QualityHub’s quality compliance experts understand how to best present objective evidence and can help interpret, preview and prepare inspection requests from the backroom.

We can help your team communicate more effectively by:

• Providing pre-interview coaching sessions
• Developing talking points
• Building storyboards to cover important topics

If you are reacting to a product quality concern, you will need to carefully document the investigation of root cause and corrective action(s) through a CAPA and implement appropriate post-market risk management activities including performing health hazard evaluations, updating risk management files, and documenting risk-based rationales for actions planned.

At the top of each FDA 483, the agency states:

“The observations noted in this Form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct all violations of the quality system requirements.”

It is important to consider how FDA’s observations may apply to your other manufacturing facilities, similar product lines, and/or related elements of the quality management system.

It may be helpful to consider having a third-party expert identify systemic issues by conducting a baseline quality management system audit or a gap assessment. Thorough quality management system audits help identify the full scope of compliance issues so you can understand the depth and breadth of possible compliance risks and react accordingly with FDA remediation.

Depending on the extent of an FDA 483 or warning letter, it may not be enough to open a few CAPAs to resolve the problem. In order to define resources and methodology for implementing systemic improvements to the quality management system, a comprehensive compliance master plan may be warranted.

Often, these plans are provided to the FDA following an inspection to help demonstrate the company’s commitment to identifying and remediating compliance issues while making systemic improvements in the areas impacted.

Whether intended for internal or external communication, a compliance master plan should provide the framework for remediation of legacy records, implementation of immediate containment or “interim” actions and implementation of appropriate improvement to the quality management system. QualityHub can provide the resources to both establish and execute a compliance plan so that you and your team can continue to support business-essential activities.

Another important activity that requires a definitive plan is the management of a widespread recall or field corrective action. Determining the need for a recall usually starts with a health hazard evaluation (HHE). The health hazard evaluation (HHE) will help identify the population at greatest risk and the extent of possible harm.

Once the management team has determined that a recall is the right action to take, it's important to develop appropriate action plans for communication with customers, the public, and the FDA. Plans need to carefully establish the scope of product involved and supporting rationale for that scope. The actions to be taken, timelines and responsibilities should all be carefully considered. A well-designed recall plan will facilitate effective communication both internally and with regulatory agencies.

When it comes to FDA remediation, the timeliness, content and tone of communication are important (whether conveying a delicate product issue to a customer or a quality event to a regulatory agency). Failure to communicate issues in a timely manner can impact customer satisfaction, compliance and (depending on the nature of the problem) even public health.

Customers respect companies who put their safety first and communicate with clarity and empathy. Similarly, regulatory agencies will respect and respond better to companies who are proactive in communicating issues with the agency, demonstrating an understanding of the company’s responsibility for quality and compliance.

Before initiating a written communication, consider getting a third-party, non-biased review to ensure effective content, clarity and tone. QualityHub’s regulatory compliance and FDA remediation experts routinely develop or review our clients intended communications with both customers and regulatory agencies to ensure effectiveness while minimizing the appearance of regulatory concern. We have experience collaborating with clients in planning meetings with the FDA and can help your leadership team prepare and present carefully scoped content.

The saying goes, “trust, but verify”.

In the case of actions taken to address FDA compliance concerns, it’s all about “verify” with much less emphasis on the “trust”. Whether corrective actions to the quality management system or product problems are documented under CAPAs or within a comprehensive compliance master plan, the effectiveness of actions taken needs to be verified by sampling and reviewing appropriate records, auditing processes, etc.

The FDA will expect verification activities are both planned with appropriate acceptance criteria and documented with reference to objective evidence.

Verification audits should always be performed by trained independent auditors who have not had direct responsibility for the area or process being reviewed. Verification audits help demonstrate that not only were the intended actions implemented but that the new processes, procedures and training have resulted in expected outputs and compliant records, thus resolving the original compliance concern.

In addition to performing independent verification audits, QualityHub also has experience performing certification audits for clients who have been asked by the FDA to provide an independent certification of the quality management system. This is sometimes requested in the case of corporate warning letters, consent decrees or where FDA has determined a company’s quality problems are recidivistic (i.e. repeated or habitual issues).