Over the past few years, I have read hundreds of FDA warning letters. A common observation that I wanted to share was the apparent difference in perceptions between the inspected organization and the FDA. My opinion is that in most cases, the inspected organization takes the FDA findings for this instance in time and often the first response is to provide a correction to “X”. The typical response from the FDA is we have reviewed your response and found it “lacks sufficient corrective actions”.
Yes, the FDA identified problem “X”. However, in most cases this problem did not start when the FDA inspector arrived, but had been ongoing for some time, and often for a very long time. The FDA would anticipate that once the inspected organization is informed of the problem, that the inspected organization would perform a root cause analysis to identify the true cause of the problem (common vs. special cause) and look at when these events may have occurred to ensure the inspected organization understands the nature (the depth and breadth) of the problem.
For example, questions that may be spurred by the finding might include, how many batches did we make under these conditions? Of these how many have been released, how many are in the warehouse? Have we received consumer feedback concerning this condition? What is the significance of the problem to the public and product? What level of containment do we need to implement? Will this cause a potential shortage? Do I need to change procedures, training, people, and equipment to provide a complete fix? What are the potential ramifications and timeline to include all of these ancillary items?
It would seem logical to look at the FDA inspection as an indicator or barometer of how well the internal controls are working. Does the outside inspection identify the same items as the internal audit program? If yes then why were not the internal inspection, correction, and corrective action adequate to fix the problem? If no, then are the internal controls adequate and at sufficient depth of knowledge to ask the right questions necessary to identify the issues? Alternatively, could this be a timing issue where production pressure minimizes the time available to dedicate to the control and oversight element?
A few ideas to consider, the next time you are tasked with responding to the agency.
Rick Van Doel
President, Performance Validation