12.7.2015 Jeff Thomas

    THe FDA is at my door - What do I do?

    Anyone regulated by the FDA will find that an inspection is like a train. There is always another one coming down the track. It might not be for another day or it might be another year, but you know they are on their way. knock.gifThe FDA agents will show up, and they will inspect places at random. If you're stuck with the question, The FDA is at my door - What do I do?, don't panic. We have the answers for you.

    What to Expect

    When you know what to expect, you can feel better prepared for a visit. The FDA may or may not announce their arrival; some agents have been known to perform surprise visits. Whether the visit is planned or not, be sure to check credentials. All agents will have identification, and you should be presented with the FDA Form 482. This form clearly highlights what the inspector is allowed to inspect, what he or she is allowed to collect, and what areas are strictly off limits.

    Be accepting of the inspection. This is not a reflection of your business - it is simply a federally regulated and necessary check. It's human nature to take an inspection a


    s an insult, especially when it comes as a surprise. However, the inspector wants to work with you, not against you. Be polite and help the inspector through the process to have a successful inspection with positive results.

    General Tips

    1. Alert Employees

    Tell employees that the FDA is arriving, if you have notification. While employees should always be working at their best, it's still important to let them know there will be an important guest. Employees can prepare and are less likely to accidentally reveal harming information.

    1. Treat Agents as Guests

    Many businesses falsely believe that a poorly treated FDA inspector will leave faster. The opposite is true. A poorly treated agent will suspect that you have something to hide. Give him or her a comfortable place, away from employees, to complete paperwork and organize material.

    1. Escort Agents to the Rest Room

    The most common place for employees to slip and reveal too much information is the restroom. It has been found that a growing number of agents find a reason to investigate extra material from information gained here. If possible, allow agents to use a private restroom, separate from employees.

    1. Designate Liaisons

    It's always wise to designate a few cool-headed employees to be FDA liaisons. The investigator may try to "trip up" employees with questions, so a level headed liaison is most likely to handle the agents in the best manner.

    1. Give Documents Sparingly

    Never hand over everything to an agent; ask what documents he or she needs. Only give what you have been asked to give, and never offer extra documents. This protects you and your company in the face of an investigation. 

    1. Understand the Forms You'll Receive

    If you receive an NAI, or No Action Indicated, congratulations! The investigator has deemed your facility efficient and you should keep operating as usual. However, if you receive a OAI, or Official Action Indicated, pay attention. This means there was a mistake discovered and you need to take action to fix the issue. Never get upset in the face of a OAI. You'll look like you have something to hide, and the investigator will get suspicious. Simply accept the paperwork with grace, and find out how to remedy the issue.

    1. Remember that the Agents Don't Want to Hurt your business

    The agent is not "out to get" anybody. Often, agents only stay with the FDA for a few years, because their jobs are taxing and they burn out quickly. They have a job to do, and they're doing it. While you don't want to reveal anything that might make them look into you further, remember that they are human. Treating them with respect will only return respect for you. It has been proven that agents who receive respect try to move the process along faster and leave your business sooner. Treat the agent as a guest and your investigation will be smoother for everyone involved

    8. The Best thing to do is to be prepared

    ZenQMS can help. If  you'd like to discuss how, just click on the button below and we will walk you through the areas that you may be putting you at risk and talk to you about how to mitigate those problems

    Published by Jeff Thomas December 7, 2015
    Jeff Thomas