WASHINGTON, DC - The medical device and pharmaceutical industries are currently facing a challenging FDA enforcement environment. A number of high-profile recalls and public health issues have put the industry in the spotlight, causing the FDA to take a closer look at how it conducts business. This is especially true in manufacturing, where lapses can cause serious issues with both drugs and devices. FDA is stepping up its inspections as it seeks to minimize the number of problem products that reach the market.
So what should you do if the FDA comes knocking? At the 2010 AdvaMed meeting, Judith Meritz, shareholder, Baker, Donelson, Bearman, Caldwell, & Berkowitz, PC, outlined the steps a company should take when facing an FDA inspection. The agency is looking for companies that, when confronted with an issue, are clearly in control of the situation, take the agency's issues seriously, and work swiftly to take corrective actions. Taking the correct steps from start to finish can keep your company out of serious trouble.
If the FDA comes calling at your company, above all else, tell the truth. Lying in response to any questions the agency asks will only cause more problems in the long run. Fully answer all questions the inspector poses, seek clarifications if you don't understand what the agency is looking for. If you don't know the answer to a particular question, refer inspectors to others who can help.
If the inspectors have found issues that need fixing, companies have 15 days to respond to the agency's findings. It's vital that your company quickly responds to the letter, conveying a sense of urgency to fix the problem. The FDA wants to see management taking its fixes seriously and dedicating the resources necessary to fix issues, and will take serious action if they believe their warnings aren't being given the proper attention. Propose a reasonable plan of action that allows you to quickly address the issues raised in the inspection. If you can't meet the deadline you set, keep the FDA in the loop with justifications for any clean-up delays.
What actions will get you in hot water? Wait too long to respond to the FDA, and inspectors will think your company isn't taking the agency seriously, leading to harsher penalties. And be careful of your response; an arrogant or dismissive tone will also put you on the agency's bad side. Finally, don't just do spot fixes of the specific issues the FDA found. Go further to really talk about systemic changes to your business.