Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance

“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detailed response along with Corrective and Preventive Actions (CAPA) has been submitted to the inspector who visited your site approximately 2 months ago. Unfortunately, clicking “send” doesn’t signify the end of your efforts. If only you had been better prepared…

Inspections by Regulatory Authorities are a standard part of the regulatory framework worldwide. It’s likely that, at some point, an inspector may evaluate your company or services.

What should you expect at the end of an inspection?

Immediate Feedback: Your Starting Point

Typically, at the end of an inspection, the inspector will provide feedback highlighting both strengths and areas of deficiency they have identified. 

This feedback is usually given verbally and may be accompanied by an informal written summary. In the U.S., receiving an FDA Form 483 is a sign Usually, at this stage, feedback isn’t graded, but rest assured, the points raised are deemed important and relevant.

The Value of Early Analysis and Successful CAPA Building

It is wise to initiate root cause analysis (RCA) and the development of CAPA soon after receiving this informal feedback. A good RCA may require some time, and usually, there is not 1 single root cause that contributed to the finding.

Identifying the primary or significant contributors to the issue is crucial for effective CAPA development. Determining the most appropriate and realistic actions based on these root causes can also be time-consuming. In the end, you’d like to end up with a CAPA that truly supports the organisation; not merely satisfies the inspector (though of course, they need to agree with it 😊).

The Trade-off of Time Gained vs. the Possibility of Rework: Why Start Early?

You might wonder why to start RCA and CAPA development before receiving the inspector’s final report. Often, inspectors may take 4 weeks or more to deliver their report but require a response within 2 to 4 weeks.

Starting early, based on initial feedback, can prevent the rush and potential for less thoughtful actions, ensuring your response genuinely supports your organization rather than just meeting perceived expectations.

Starting the process based on informal feedback therefore buys you valuable time, and it will rarely be a useless exercise if the informal feedback focuses on areas that matter in the eyes of the inspector.

After receiving the final report, you may fine-tune your RCA and CAPA as necessary, but complete rework is rarely needed. This approach also allows you to consider new information that may emerge post-inspection.

Beyond “Send”: The Importance of Follow-through

Submitting your response does not end the inspection process. Depending on your commitments and organizational structure, improvement teams and CAPA managers might need to ensure these commitments are met and evidence of effectiveness is compiled. Even if not requested, maintaining this evidence is crucial, as inspectors may return.

Throughout these weeks of intense collaboration, amidst stress, negotiations, and more, the question remains: Could I have been better prepared? Could these findings have been avoided?

The answer is yes. Many, if not all, findings could likely have been prevented.

Note: This approach is also applicable to audits by certifying/notified bodies or significant internal audits (or for service providers: key client audits).