Our warning letter from the FDA

Sorry for the long post but this is a topic that is just too important to address in tweet form so to speak. So bear with me.

This summer the FDA came to Cook Inc. in Bloomington for a routine inspection of our facilities and manufacturing processes. Throughout the inspection the FDA auditors took a much different approach than what we have experienced in the past.

Their questions, comments, and findings challenged our thinking and, quite honestly, forced us to take a second look at how we monitor our manufacturing processes. They asked tough questions, demanded quick answers, and wanted data to support our conclusions. All things an experienced inspector should do.

At the end of the inspection, the auditors summarized their findings in a document called an FDA Form 483. They listed eight observations that they thought needed to be addressed. Following standard process, we responded with our corrective action plan for the items listed in the 483. The FDA then took the next formal step and issued what’s called a Warning Letter to Cook Inc. on September 18. Such warning letters are made more public than the Form 483, and our letter will appear on the FDA’s public website in the next few days. Follow the link to their site if you are interested in reading the letter in detail.

Essentially, the warning letter restated the observations of the 483 and asked us to work as quickly as possible to ensure that the concerns are addressed. We never like to see negative comments from an FDA inspection, but when it happens we’re going to do whatever we can to make it right. And we are going to get it done as fast as we possibly can.

During the inspection, the FDA identified three general areas of non-compliance within our quality system: process validation (the methods we use to ensure that our processes for building products are tested to be adequately reliable), handling of non-conformances (how we track product made during production that doesn’t meet our standards), and assessment of quality data (how we analyze the data we collect). Some have asked if this is similar to  a recall. It is not. The warning letter asks us to improve our internal systems. It doesn’t affect product that is shipped out to customers.

Cook has always been known for a very high level of product quality. We see this inspection as an indication that we can be even better. Our intent is to not only address the agency’s specific concerns, but to get ahead of regulatory expectations.

I want to be clear. This is a big project and it will affect virtually every person that works for Cook. It’s going to be all hands on deck. For example, we have asked the majority of our engineering and information technology teams to put aside their current projects and to concentrate their efforts on implementing the necessary changes to our quality system. Manufacturing teams will be asked to make additional product to support all of the required testing. And our business units will likely see a delay in new products moving through the development process. It will truly be a team effort.

We have already begun to implement changes to our systems in Bloomington, Spencer, Canton, and Ellettsville. Even though the FDA inspection did not cover our other facilities, we are going to take a look at them too. We will attack any challenges we find with the same high priority.

The next few months are going to demand a lot from all of us. We are moving as fast as we can to work through these challenges because the FDA has demanded that we do so. But more importantly, we are going to improve our systems because we know that we will have a more efficient manufacturing system when we are done — and that we will have raised the bar even higher on our own expectations for quality and patient safety.

Thank you all for your support and hard work. We will keep you updated as work progresses.

– Pete