White Paper

How to Survive an FDA Audit: 3 Crucial Steps

For pharma companies, FDA audits are a regular part of life. Instead of dreading the inevitable, take the auditor by the horns* by learning how to best prepare.

*Results may vary; take proverbs with a grain of sodium chloride.

August 19, 2022

Industry Perspective

When you hear the words “FDA audit,” do your palms get sweaty and does panic set in?

If so, you’re not alone. For many drug manufacturing professionals, the idea of an FDA inspection can be anxiety-inducing and even overwhelming. But the reality is, the Food and Drug Administration serves an important purpose — assessing the safety and quality of the food, medications, and biological products sold to consumers. And that’s why audits are necessary: to ensure manufacturers are complying with the regulatory requirements needed to keep patients safe

In this article, we’ll dive into the purpose and structure of FDA audits: why they’re so crucial, and what you can expect to happen during and after an audit. We’ll then tell you three steps you can take to help your organization pass with flying colors.

Jump to…

FDA Audit: An Overview

What Is an FDA Audit?

An FDA audit is when the Food and Drug Administration (FDA) routinely inspects regulated facilities, such as drug manufacturers. Generally, these inspections occur once every two years, but they may happen more frequently. 

Audits happen for a variety of reasons, including: 

  • Routine inspections
  • New drug applications
  • Complaints or safety issues 

During an FDA audit, the inspector will review the systems and documents (following the batch/test approach), and then conduct an exit interview with the drug manufacturing management team to review their findings. 

What Is the Purpose of an FDA Audit?

The purpose of an audit from the FDA is to ensure pharma and other manufacturing organizations maintain compliance with the FDA’s standard operating procedures (SOPs), Current Good Manufacturing Practices (cGMPs), and other regulatory guidelines.

Compliance with these guidelines ensures that human (and animal) safety and wellbeing is protected. Pharma manufacturing is complex and multifaceted, which is why the audits are ongoing. In addition, the regulatory guidelines change from time to time, and the FDA conducts inspections accordingly.

What Happens after an FDA Audit?

After each inspection, the FDA classifies its findings into one of the following three categories:

  • No Action Indicated: This classification, also known as “NAI,” means all is well and the organization is compliant with FDA requirements. 
  • Voluntary Action Indicated: “VAI” classification means the FDA has found objectionable conditions or practices, but these findings aren’t serious enough to merit administrative or regulatory action. 
  • Official Action Indicated: An “OAI” classification means the manufacturing organization isn’t compliant with the regulations set forth by the FDA. When an OAI is issued, the FDA makes recommendations and the organization is required to take corrective action.

What Is a Form 483?

When the FDA determines conditions violate the Food and Drug Cosmetic (FD&C) Act, it issues a Form 483. This form details the violations and objectionable conditions found during inspection.

Reasons for an FDA Form 483 include:

  • Procedures don’t meet FDA requirements in one or more area 
  • Procedures meet FDA standards but aren’t followed fully 
  • Procedures conform to FDA regulations and are followed, but not documented correctly 

If corrective action isn’t taken, based on FDA recommendations, the FDA may revoke distribution rights for existing products or deny approval of pending applications.

Now, let’s explore 3 steps you can take to survive an FDA audit — and avoid the dreaded warning letter.

3 Steps to Surviving an FDA Audit

Step #1: Know the Inspection Guidelines

Knowledge is power. And when it comes to FDA inspections, you want as much power in your corner as you can get.

No one likes to be tested on something they aren’t prepared for. That’s why the #1 step to surviving an FDA audit is to know the inspection guidelines.

For routine inspections, the FDA personnel will examine of the following departments:

  • Quality 
  • Production and equipment 
  • Materials
  • Production
  • Packaging and labeling
  • Laboratory control

Additionally, the inspector will review supporting documentation, which we’ll discuss in step #2. These documents will help the inspector determine if an organization is adhering to the FDA’s cGMP guidelines.

Step #2: Prepare in Advance

FDA audits are an ongoing part of the drug development and manufacturing process. As such, it’s important to keep them on your radar so you can prepare in advance.

You’ll want to start by assembling a readiness team that consists of operational managers who know the SOPs and cGMPs inside out across every department and system. These people will help your organization prepare by conducting random internal inspections. They’ll be looking for any issues that would lead to a 483 form and ensure your organization is on the right track.

In addition, they’ll also prepare all necessary documentation in advance and serve as the FDA auditor’s point of contact throughout the inspection process. This includes answering questions, gathering information, and providing data to the inspector as requested.

Step #3: Conduct Internal Inspections

For routine inspections, the FDA isn’t obligated to give you an advance notice before showing up. For the unprepared, panic sets in and everyone working may feel anxious or overwhelmed.

That’s why it’s a good idea to conduct regular internal inspections. In-house audits will help your team prepare for a surprise visit, plus it gives your internal readiness team an opportunity to role play in advance.

Any missing documentation, equipment or system failures, or other issues can be addressed in real time, without receiving a warning letter from the FDA. Plus, routine inspections will hold your team accountable and reiterate the importance of upholding the FDA’s SOPs, cGMPs, and other guidelines.

An FDA Audit Is Coming: Are You Ready?

Your next inspection may happen in 12 months or two days — regardless, it’s coming. Instead of dreading it or scrambling to prepare last minute, set your organization up for success by:

  • Familiarizing yourself with the inspection guidelines
  • Preparing a readiness team, workspace, and the documentation 
  • Conducting regular internal inspections 

As you work through the steps above, you may find yourself feeling overwhelmed. Take it one step at a time. Full preparation won’t happen overnight.

If you realize there’s too much documentation scattered everywhere, and you’re ready for a better way, start evaluating unified, cloud-based solutions (like this one). The right tech can help your organization improve safety, yield, and quality while upholding compliance standards.

Our Featured Thought Leader

When it comes to FDA audits, Keith Bowen is the go-to resource you want on your team. And we’re lucky to have him on our team here at Apprentice! 

Read on to meet Keith and learn his top FDA takeaway:

Keith’s Background

With 24 years of experience in the life science industry, Keith is well respected for his knowledge of and experience with MES product development, solution design, system integration, implementations, and support services for both large and small MES projects.

Keith has worked with many of the Top 10 Pharma, Biotech and Medical Device companies, on both automation and MES solutions. Today, he is an MES/LES Advocate at Apprentice and works primarily with new customer engagement, interfacing between sales, product, and marketing.

Keith’s Top FDA Takeaway

"Regulatory audits are an essential part of life science manufacturing to protect patient safety (human or animal).

For the prepared, it is an exciting opportunity to either begin supplying products to those who really need them or maintaining the privilege to do so. For the unprepared, it is absolute panic!

My advice is to be fully electronic and have everything at your fingertips.”

References

  1. Center for Drug Evaluation and Research. (2020, September 21). Current Good Manufacturing Practice (CGMP) Regulations. U.S. Food and Drug Administration. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
  2. Office of Regulatory Affairs. (2020a, January 9). FDA Form 483 Frequently Asked Questions. U.S. Food and Drug Administration. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
  3. Office of Regulatory Affairs. (2020, May 11). Inspections Database Frequently Asked Questions. U.S. Food and Drug Administration. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions#inspection
  4. U.S. Food and Drug Administration. (2015, January). Developing, Issuing and Maintaining Standard Operating Procedures for CDER. https://www.fda.gov/files/about%20fda/published/Developing--Issuing-and-Maintaining-Standard-Operating-Procedures-for-CDER.pdf