With the number of recalls for medical devices and other products, the FDA has become more aggressive about inspecting facilities and making sure companies are complying with the rules and regulations designed to protect consumers from faulty or dangerous products. If you received a notice from the FDA that it's coming to inspect your facility, here are two tips to help you prepare for the visit.
Perform Internal Audits
The best thing you can do is perform an internal quality audit of your facility that's the same as or tougher than the inspection you'll undergo when the FDA representative tours your facility. Auditing your facility in this fashion will help you identify issues that may be cause for concern and fix them before those issues are highlighted by the FDA agent and possibly result in your company getting fined or shut down.
You can find FDA inspection guides for a variety of industries on the government agency's website. There may also be books and other products developed by private individuals that can help you put together an internal audit program that prepares you for the FDA inspection and possibly increase the overall quality, productivity, and efficiency of your company.
Prepare Your Employees
FDA inspections sound intimidating, and your employees may be nervous about the event. Workers may be afraid that if the company doesn't pass the inspection, they may lose their jobs or suffer other consequences. This, in turn, may lead them to say or do things during the inspection that could hinder your chances of passing.
The best thing you can do is talk to your employees about the inspection. Educate them on what to expect when the FDA agent arrives and coach them on how to behave around and interact with the inspector when the person comes through their area.
It may be extraordinarily helpful to perform one or two mock FDA inspections with employees so they can get a clear idea of what is expected of them. It's probably best to have someone who your employees don't know (but who is known to you) to act as the inspector. Alternatively, you can have your attorney step into this role. He or she can identify any legal issue that may come up in the course of your employees interacting with the inspector and advise you on the best way to handle them.
Getting through an FDA inspection can be challenging. With the right preparations, however, you can get through it successfully. For more information about or assistance with this issue, contact Mohajerian A Professional Law Corporation or a similar firm.