The FDA 483 Response – Re-establishing Credibility
Once observations are given, particularly critical or major points, the firm has a limited amount of time to respond. 15 days!!! Work to put a time frame around the response in place and adhere to it diligently. This is the firms chance to re-establish credibility with the FDA.
The last thing an auditor or auditor body wants to do is “chase down” a firm for corrective actions or to conduct extensive follow-up – The FDA will NOT do it. Any issues with your FDA 483 response such as lack of clarity or detail will only result in a request for further information, followed by more details, followed by another review, etc. This loss of time in obtaining a conclusion to the audit can result in your firm’s credibility going down the drain fast.
Steps For A FDA 483 Response
An approach for formulating a response on each observation is recommended as follows:
- Evaluate the current state of compliance in light of the audit observation. If possible, indicate what is compliant.
- Identify the root cause of the issue as appropriate. Understand how the firm will resolve the issue systemically.
- Review prior commitments. Are any issues a repeat observation or a repeat observation for the same type system issue? This is critical to know and understand. If you have made a commitment in the past regarding an observation but the corrective actions were not implemented or did not resolve the issue, the inspecting body will evaluate the current observations in a more critical light. Repeat observations also greatly increase the likelihood of further regulatory actions.
- Identify the root cause. This is a fundamental principle in the FDA’s view of systemic audits and is certainly used widely in Europe as a format for inspections.
- Relate each observation to the appropriate Quality System. Understand the area of impact of the issue in relation to the functions impacted by that “system”.
- Develop a corrective action plan around the entire scope of the issue(s) noted.
- Secure the required resources needed to complete the job in the time frame indicated. DO NOT underestimate the forces needed to complete a job within schedule – let alone evaluating the outcome of the work.
- Verify that responsibilities are assigned to key people and make them accountable. Assignments given to “departments” or groups of people are almost doomed to failure. Someone has to be in charge, assign work, track and modify the assignment as needed. Just as important, a single key individual, typically the head of quality, will need to be responsible for the overall work.
Note that in the steps just provided, points 1 through 7 are directly related to formulating a response to the observation. It is critical to understand that points 6 and 7 directly relate to the response letter in that these actions determine the time frame in which actions can be accomplished.
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.