FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any company. Exaggeration? Perhaps, but ask anyone who was part of a company that received one – and words like “devastating”, “nightmare” or “shock” will likely describe their reaction. Some people within the company may have “seen it coming” (hindsight is always 20-20), but it is generally a shock when it actually happens. This is the one reason many recipients of a FDA Warning Letter quickly obtain remediation help from a reputable outside firm.
But why did it happen? How did so many compliance problems pile up that FDA decided it was time to issue the company a Warning Letter? Yes, Root Cause Analysis tools are available to identify the most obvious cause of each individual FDA finding, but those methods don’t necessarily answer the question of “Why so many compliance problems?”
In our experience, the primary root cause for compliance problems is often not just one element of a quality system. Compliance problems are often enabled or incentivized by other issues, like HR policies, corporate structure or company culture. Thus, it is often difficult for quality personnel to effectively address questions like:
Effective compliance remediation is rarely simple. The changes that need to be made are not always obvious. Understanding how to identify and address these complex issues is critical and can lead to future efficiencies in compliance. It is generally easier for an outside firm to make these assessments. This is a second reason why outside remediation help is important.
In our experience at MED Institute, FDA does not expect perfection in a quality system. Being compliant does not mean that everything is perfect and no one makes mistakes. Being compliant means that the systems are properly established and maintained so that they identify mistakes, reliably correct them, and prevent them from occurring in the future. Being compliant means mistakes do not get ignored or hidden and are not allowed to grow. The question is not “How many mistakes have been made?” Instead, the question is “Are mistakes being addressed, with a timely, effective, efficient and consistent process?” In some sense, FDA is looking for a quality system that will continue to improve after the Warning Letter is lifted. The benefit of periodic review and audit is a third reason why companies use outside remediation help.
The goal of remediation is really to keep 483s from turning into Warning Letters and to keep Warning Letters from turning into Consent Decrees, all through efficient compliance with quality system requirements. Successfully reaching the goal requires experience with the complicated dynamics of FDA compliance and how company culture, quality system structure, HR issues and other factors are critical to efficient compliance programs. When we assist clients who have received a 483 or Warning Letter, we obviously focus on addressing FDA findings, identifying root causes, and improving quality procedures for efficiency in the future. By understanding the impact of cultural factors that affect compliance, gaining and maintaining reasonable and efficient compliance with FDA regulations is possible, with outside remediation assistance providing the tools for success.