Navigating FDA Inspections: Tips for a Smooth Process

FDA inspections can be stressful.

How do you prepare? If you’re lucky, you’ll have a few weeks’ notice, but you could end up with as little as five days.

In the long term, the best way to ensure a smooth FDA inspection process is to cultivate a culture of compliance within your organization. There are many long-term tips for maximizing compliance, but if there are areas where your organization is lacking, you certainly won’t have time to fix them by the time you get notice of an FDA inspection.

Here are a few practical tips for preparing for an FDA inspection in the time that you’ll have.

Know What to Expect

After your FDA investigators introduce themselves and show their credentials, their best order of business will be to “verify and/or gather administrative information.” They’ll look at paperwork and ask questions about the business overall, then review operational information for select products.

Next will be the walkthrough of the facility. They’ll observe processes, procedures, and employee practices. They’ll probably review written procedures and records as they go, and they may speak with employees to learn how closely those documents are being followed.

After the walkthrough, investigators will ask for additional records on specific areas of the operation that interest them.

At the end, they’ll provide you with a written list of “significant inspectional observations” and may discuss any smaller problems they saw. This will be your chance to ask questions and discuss corrective actions for moving forward.

You’ll be required to submit a written response about all corrective actions within 15 working days of the end of the inspection.

Line Up Paperwork and Subject Matter Experts

In the weeks or days leading up to the inspection, you need to gather and organize all the documentation you may need to provide.

It’s also a good idea to line up subject matter experts (SMEs) capable of answering questions in various knowledge arenas and ensure that they’ll be there on the day. If possible, arrange for a backup SME in each area just in case your primary choice is unavailable. If you have enough lead-up time, practice interviews and help all SMEs and backups prepare.

Review Past Corrective Actions

You absolutely must review past inspections and their results.

If you’ve previously been dinged for public health concerns, you’ll be expected to speak about corrective actions you’ve taken. Make sure relevant paperwork is available and that both management and SMEs are prepared to speak on these topics as needed.

Investigators will pay special attention to verifying these corrective actions during their walkthrough, so you should prioritize making sure these changes are being followed to the letter.

Respond to Observations with an Actionable Plan

Pay special attention to making sure you meet the 15-day deadline in your written response to any observations. You want your response to be robust and thorough in the form of a Corrective and Preventative Action (CAPA) Plan.

Implement the changes in a timely manner.

Train Employees for Success

Providing compliance training for employees is an important part of making sure your FDA inspections go smoothly. As a training provider with over 20 years of experience in compliance education, we can help! Check out our food manager certification and other food safety offerings and enroll today!