The Most Important Details of a Corrective Action Plan – (CAPA)

Imagine the sheer volume of warning letters the FDA sends out to companies who are not meeting FDA regulations. The companies will no doubt reply back with a presentation to resolve the FDA compliance issues right?

With the sheer volume of work involved would the FDA show any remorse for these companies? Generally the answer is no, the FDA’s response would be a fairly “neutral” expression.

Now consider for a moment the work involved for the company once they have received one of these warning letters. The executives from the company will construct a Corrective Action Plan presentation with the help from the company’s lawyers, the presentation will then be examined, and re-examined to be sure to meet the FDA’s necessary regulations the company may have missed the first time.

Generally once the executives, and company’s lawyers have had a look over the presentation, a third party will be called in. The third partywill consist of experienced consultants to check if there are any areas in the presentation, which might have been missed. Normally the FDA will be looking for things like: a timeline and a cohesive plan for the corrective actions.

Once all has been done and dusted, and the presentation has been approved for the FDA. A qualified representative from the company will make the long march down to the FDA district office to present the corrective action plan presentation.

But what if the FDA had changed its strategy in what they are looking for in these corrective action plans? The company, which received the letter, would have to change its presentation to the FDA’s new strategy, would it not?

Well that’s what the FDA has done. Currently the FDA are looking for an exact plan to correct the regulations which have been broken as well as the data to support why the effectiveness of the plan will fix the non compliance issues. Not to mention that the FDA are also looking for the resources allocated to address the issues and for the entire compliance plan.

Does that not seem entirely unrealistic to expect all of these things from a company, which may have a very small budget?

In the past a detailed corrective action plan and timeline would’ve been acceptable for the FDA. They would then follow up with the company in the future with either they have been approved or if they have not been approved.

But now presenting a clear picture of the resources it takes to get to compliance is now part of a successful presentation. Projects with the highest success rates include the individuals who are directly responsible for the corrective actions.

The project will generally include individuals which have the resources clearly identified to execute the work to be done.

The FDA has finally realized that these are integral details that belong in a well-rounded corrective action plan. Better late than never!!

It seems that this is a step in the right direction by the FDA, finally ensuring corrective action in a timely fashion.