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Jeff Thomas12/07/153 min read

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

Life sciences organizations regulated by the FDA will find that an inspection is like a train; there's always another one coming down the track. It might not occur today or tomorrow, but it's on its way eventually. When FDA agents do show up to inspect your site without much warning, try not to panic. And read on for more tips on how to proceed.

What to Expect:

When you know what to expect from an FDA audit, you'll be better prepared for the visit. The FDA may or may not announce their arrival; some agents have been known to perform surprise visits. Regardless of whether their visit is planned or not, be sure to check their credentials. All agents will have identification and will present you 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's simply a federally-regulated and necessary check. It's human nature to take an inspection as 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

If you've been prior notification, alert employees that the FDA are on their way. While employees should always be working diligently, it's still important to let them know an important guest will be on the premises. Prepared employees will be less likely to reveal harmful information accidentally.

  • Treat agents as guests

Many businesses erroneously believe that poorly treated FDA agents will leave faster. The opposite is true. A poorly treated agent will suspect that you have something to hide and may make additional requests. Give them a quiet, comfortable space, away from employees, to organize material and complete their investigation.

  • Escort agents to the rest room

Believe it or not, the most common place for employees to slip up and reveal too much information is the restroom. It's been found that a growing number of agents find a reason to investigate extra material from information gained there. If possible, allow agents to use a private restroom, separate from employees.

  • Designate liaisons

It's always wise to assign a few cool-headed employees to be FDA liaisons while at your site. Investigators may try to "trip up" employees with questions, so having designated liaisons speak on behalf of the organization and handle their queries is preferable.

  • Give documents sparingly

Never hand over everything to an agent or allow all-access to your files. Give what they have asked for and nothing more. With an electronic quality management system (eQMS) companies can to set up a private account for inspectors to view their requested documents. This prevents the agent from being overwhelmed, and protects the company from disclosing documents they may not want the inspector to read.

  • 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 can continue 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 take steps to remedy the issue.

  • Remember, 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 elicit further scrutiny, remember that they are human. Treating agents 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 them as guests and the investigation process will be smoother for everyone involved.

  • The best thing to do is to be prepared

ZenQMS has tools that can reduce the stress surrounding an audit.  Talk to us. We can help.

 

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