A Basic Guide to Mock FDA Inspections/Audits

A mock FDA inspection—sometimes called a mock FDA audit—is the internal process companies within the FDA-regulated industries use to assess their compliance with FDA regulations and overall readiness for an actual FDA inspection. The goal is to identify any potential shortcomings or gaps that could be problematic during a real inspection so they can be addressed before regulators arrive.

Mock FDA inspections are critical for identifying issues that could affect the quality of manufactured products and become compliance issues with FDA expectations.

As such, every firm in the FDA-regulated industries subject to an inspection should understand what a mock FDA inspection or audit is, why they should arrange for them to be conducted, and what that audit should entail.

In October of 2020, we sat down with a former FDA Investigator and current FDA Group consultant, Christopher Smith, to discuss Pre-Approval Inspections (PAIs) in an episode of The FDA Group's podcast, The Life Science Rundown. Watch the full episode below and read on for a clear and simple deep dive into PAIs.

Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

What is a Mock FDA Inspection/Audit?

The general objectives of mock FDA inspections are:

1. Strategize and prepare for actual FDA inspections.
2. Detect non-compliant practices and correct them prior to actual FDA inspections.
3. Help staff members practice their roles and responsibilities during inspections.
4. Verify that the company's quality systems are effective and in control.
5. Predict potential FDA inspection scenarios.
6. Equip personnel technically and emotionally for actual FDA inspections.

Again, there's no functional difference between a mock FDA "audit" and a mock FDA "inspection." The terms "audit" and "inspection" are often used interchangeably. However, technically speaking, FDA inspectors are not auditors. That said, the type of project we're referring to is, in fact, an audit.

External consultants almost always perform mock FDA inspections/audits, sometimes former FDA staff, mock FDA inspections are designed to uncover deficiencies and ensure alignment with FDA regulations.

To unpack this a bit further, a mock inspection provides a comprehensive understanding of your organization's standing concerning GxP expectations and other dimensions of regulatory compliance relevant to the product space.

But a mock inspection is much more than simply checking regulatory compliance. A major part of it also includes preparing the company's personnel for hosting an FDA investigator. A great auditor, especially one with direct experience in the FDA, can reveal gaps in understanding, communication, or readiness that could be problematic during an actual inspection.

Here at The FDA Group, for example, our auditors sometimes go so far as to prepare "storyboards" that subject matter experts can review before speaking to an investigator—essentially choreographing the motions of an inspection in fine detail.

It also sheds light on an FDA inspection's less tangible, more operational components that can often get overlooked.

For example, a well-run mock FDA inspection will reveal:

• How individual staff behave around, and interact with, an FDA investigator.
• How well your inspection "war room" is set up to facilitate an inspection in terms of fast access to records and documents, ability to answer questions, etc.
• How effective your processes are for hosting an inspection, and whether your team's roles during an inspection have been established and rehearsed.

Findings from mock FDA audits can spark remediation projects where companies have to respond to observations and create remedial plans. This process mimics the procedure a company would need to follow if actual FDA inspections found compliance issues.

Types of mock FDA inspections/audits

There are several types of mock FDA inspections we help firms conduct to prepare them for the different scenarios that prompt a real FDA inspection.

Here are some specific types of mock FDA inspections—all of which we routinely conduct for FDA-regulated firms:

Pre-approval Inspection (PAI) Mock Inspections

These are performed to assess a company's readiness for a Pre-Approval Inspection by the FDA, which is required to approve a new product or a significant change to an existing product. These mock inspections usually include (but certainly aren't limited to) an evaluation of the clinical data supporting the product, a review of manufacturing processes, and an examination of quality control procedures.

Firms have to be prepared to defend, among other things, their clinical study data integrity and adherence to protocols during the PAI, so running a mock inspection is critical. 

• Read our guide to PAI preparation for a deeper dive.

GMP Compliance Mock Inspections

These very common audits assess a company's adherence to Good Manufacturing Practices (GMP) as required by the FDA. The inspections cover various aspects of manufacturing, including cleanliness, validation of equipment and processes, and documentation of procedures.

Remember that the FDA doesn't just look for adherence to GMP at the moment of inspection but also seeks to understand how consistently these practices are maintained over time. Teams need to produce meticulous historical records demonstrating regular adherence to GMP, not just a spotless facility at the time of inspection.

GLP Compliance Mock Inspections

These are conducted to evaluate a company's adherence to Good Laboratory Practices (GLP) regulations. They typically involve a review of the company's facilities, equipment, personnel, methods, practices, records, and controls used in nonclinical laboratory studies.

Remember that the FDA won't just be looking at your data but how that data is collected, recorded, and stored. Changes to data, no matter how insignificant they might seem, need to be tracked, justified, and documented. A great auditor can examine these intricacies in extreme detail.

GCP Compliance Mock Inspections

These assess a company's compliance with Good Clinical Practices (GCP), which are required for clinical trials. These inspections typically include a review of the study protocol, informed consent procedures, and data integrity.

FDA is particularly interested in patient rights and safety. It's important to demonstrate patient informed consent and ensure patients understand the trials. The FDA may interview trial participants to confirm they fully understand what they've consented to.

💡 Note that very often, multiple areas of "GxP" can be addressed in a single mock FDA inspection/audit. This broader mock inspection covers all areas that the FDA might review during an actual inspection. It includes elements of GMP, GLP, and GCP inspections and evaluations of quality systems, labeling, and regulatory compliance. During a comprehensive mock FDA audit, auditors may examine the company culture around compliance and quality. FDA wants to see a "culture of quality," where every member of the organization understands their role in maintaining compliance and product quality.  

These audits are recommended regularly to ensure a company's readiness for an unexpected FDA inspection. It's particularly important when a company has experienced significant growth or changes, has had previous compliance issues, or is operating in an area of high regulatory scrutiny.

BIMO Mock Inspections

These focus on Bioresearch Monitoring Program (BIMO) compliance. The FDA's BIMO program is designed to monitor all aspects of the conduct and reporting of FDA-regulated research and to ensure the rights, safety, and welfare of the subjects of the research and the quality and integrity of the data collected.

FDA's BIMO program involves an interdisciplinary approach to conducting and reporting FDA-regulated research. FDA investigators may cross-verify data from different departments and disciplines to ensure the validity of the clinical trial data.

For-cause Mock Inspections

These are audits conducted when there's a suspicion of non-compliance or in response to a specific issue that has been identified following an enforcement action. While these inspections focus on the specific issue of concern, they can lead to broader investigations if the issue indicates systemic problems. Effectively addressing the root cause of an identified issue can prevent a small problem from turning into a larger, systemic issue.

Internal vs. external mock FDA inspections/audits

We sometimes encounter some confusion around internal versus external audits. Most of the time, mock FDA inspections are internal. This means the company is assessing its own (hence, "internal") operation rather than evaluating an external entity like a supplier or distributor.

Only the largest and globally distributed companies tend to manage their own internal auditing teams that travel their sites. So, most companies call on third-party auditing consultants (like The FDA Group) to plan, conduct, and report the findings of these mock inspections. These teams usually comprise ex-regulators. 

Consultants essentially simulate an actual FDA inspection at the site or facility—conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation projects.

External mock FDA inspections are used when a firm wants to hire a consultant to audit their contract manufacturing organizations (CMOs) or other external suppliers.

What's the Typical Format For a Mock FDA Inspection/Audit?

While the specific details may vary depending on the complexity and size of the facility and the nature of its products or services, a typical mock FDA inspection/audit follows a schedule somewhat like the following "generic" plan:

Day 1: Opening Meeting and Facility Walkthrough

The mock inspection will usually start with an opening meeting to explain the plan. This includes what will be audited or "mock inspected," the scope of the inspection, and the process that will be followed.

This first day often includes a thorough walkthrough of the facility, similar to what would happen during a real FDA inspection. This helps identify any obvious issues with the facility itself, such as cleanliness, organization, safety, or general operations.

Day 2-4: In-depth Assessment of Key Areas

The following days will typically involve in-depth reviews of specific areas of operation. This often includes, but is certainly not limited to:

• Quality Management System (QMS): The auditor will review the company's QMS to ensure it is robust, well-documented, compliant, and being followed as written.
• Product Development: This includes a review of design controls, verification, and validation activities, and change control processes.
• Production and Process Controls (P&PC): A thorough review of the company's manufacturing processes will be performed to ensure they comply with FDA regulations.
• Records and Documentation: Inspectors will review the documentation for consistency, completeness, and adherence to requirements. This includes looking at how data is recorded, reviewed, and approved.
• Complaints, Corrective and Preventive Actions (CAPA), and Recalls: The inspection will review how the company handles complaints, manages CAPAs, and handles recalls if necessary.

Final Day

On the final day, the auditor will typically review any last-minute areas, follow up on any open items from the previous days, and prepare for the closing meeting.

The closing meeting: During the closing meeting, the auditor will provide a summary of their findings, including any observations that might be considered non-compliant during an actual FDA inspection. This allows the company to discuss the findings and understand what needs to be done to correct any identified issues. 

Again, the duration and content of the mock inspection may vary depending on the company size, product portfolio, and regulatory history. The ultimate goal is to ensure the company is fully prepared and compliant for a real FDA inspection.

What Specific Activities Comprise a Mock FDA Inspection/Audit?

A mock FDA inspection aims to simulate an actual FDA inspection.

Here's a high-level breakdown of the activities that take place throughout the process:

• Planning and Prep: The first step involves planning the inspection. This includes deciding on the scope of the audit, the departments or processes to be audited, and the schedule.
• Use of FDA Inspection Guide(s): An auditor will use an FDA inspection guide or other appropriate compliance program guidance manuals. This ensures that the mock inspection is as close to an actual FDA inspection as possible. 
  
• Review of Documentation and Records: A mock FDA inspection involves a thorough review of all relevant documentation. This includes but is not limited to, Standard Operating Procedures (SOPs), product specifications, quality management system (QMS) records, training records, and any previous audit findings and corrective actions.
• Site Inspection: An auditor will physically inspect the manufacturing facilities, labs, and other relevant areas to assess compliance with Good Manufacturing Practices (GMP) and other applicable regulations and expectations. They will also observe processes and workflows, interact with employees, and assess the company's state of control over its operations.
• Interviews with Key Personnel: As part of the mock inspection, an auditor will interview key personnel. This serves two purposes: verifying information obtained from documentation and assessing the readiness and competence of staff to handle the pressure of an actual FDA inspection.
• Findings and Reporting: The auditor will note any observed non-compliance issues or gaps, which will then be compiled into an audit report. This report will detail observations and provide recommendations for corrective actions. 
• Remediation and Training: Based on the audit findings, the company can initiate a remediation plan to address identified gaps and prepare for an actual FDA inspection. This could include re-training staff, revising procedures, improving documentation, or addressing specific non-compliance issues.
• Post-audit Review: The last stage of the mock inspection involves a post-audit review where the auditor discusses the findings with the company and provides feedback on their responses to observations. This exercise can also help the company prepare to respond appropriately during a real FDA inspection.
  

How Can You Apply the Results of a Mock FDA Audit?

The results of a mock FDA inspection are meant to serve as a diagnostic tool, identifying both strengths and areas of potential weakness within your organization's regulatory compliance framework.

Addressing the issues that were identified is the first and most obvious next step. Internal RA/QA and other impacted teams use the report as a guide to take action on any non-compliance issues or gaps identified during the audit. This may involve reviewing and modifying SOPs, adjusting manufacturing or quality control processes, retraining staff, or implementing new control measures.

For more significant findings, developing and executing a formal remediation plan may also be necessary. This should outline the steps that will be taken to address each issue, the expected timeline for each action, and the individuals or teams responsible for each task. (Here at The FDA Group, audits that result in findings warranting significant remediation are often handled by the auditors themselves as an extension of their project, or additional resources are brought in based on the skills and proficiencies required to address the issues.)

Another (sometimes less apparent) application of these mock inspections is training and education. Mock FDA inspections and the auditors running them offer a unique and invaluable way to train and gain critical knowledge about inspection readiness. Auditors and internal leaders can use this opportunity to educate staff about the findings and reinforce the importance of FDA regulations and the potential consequences of non-compliance. It can also be beneficial to use this as a training session for what to expect during a real FDA inspection, including answering questions from inspectors and demonstrating compliance effectively.

Of course, another application is optimizing inspection readiness. Mock FDA inspections/audits highlight how prepared—or unprepared—your team is for when real FDA investigators walk through the door. This could prompt a review of your inspection readiness plan and inspire additional preparations, such as creating or improving a "war room", preparing data and documents, or holding practice sessions for potential questions from FDA inspectors.

Regular mock inspections also provide ongoing insights into your compliance status and, over time, can help drive continuous improvement. They can also help to embed a culture of quality and compliance within your organization as employees become more familiar with the process and requirements.

Lastly, the insights from a mock FDA inspection/audit can feed into your broader risk management program. By identifying potential compliance risks early, you can take proactive steps to mitigate these risks before they become larger issues.

Tips for Teams Preparing for a Mock FDA Inspection/Audit

While it's obvious that RA/QA teams should be well-versed in the regulations that apply to their products and processes and that they should have all necessary documentation in order, there are indeed some less obvious ways teams can prepare for a mock inspection.

Here are some tips that sometimes aren't so obvious:

• Create a Comfortable Environment: While it's not directly related to compliance, ensuring that the auditor—and eventually the FDA investigator—is comfortable can contribute to a successful audit. This could involve providing a quiet, private space for them to work, being available for questions, offering refreshments, and maintaining a positive, cooperative attitude. 
• Prepare for Tangents: Don't expect to stay married to a rigid schedule; mock and real inspections often diverge from the planned scope or schedule due to unforeseen issues or areas of interest. Being prepared for this flexibility can help the team respond appropriately and quickly. Build in buffers of time around everyone's schedule. Expect things to take longer than they should.
• Educate Other Staff: Often, the focus of audit preparation is on the RA/QA team, but it's important to remember that auditors and inspectors will interact with other staff members, too. Providing a basic level of regulatory awareness training to all employees, along with clear instructions on how to interact with auditors, can be very helpful.
• Develop a Clear Narrative: Craft your compliance journey into a story to the extent possible. This story should outline the company's history, improvements made over time, challenges faced, and how they were overcome. A well-prepared narrative can provide context and showcase a company's commitment to continual improvement, positively influencing the auditor's or investigator's perception.
• Anticipate Questions Ahead of Time: Brainstorm and anticipate potential questions the auditor and investigator might ask. This not only helps prepare answers but also allows identifying potential areas of concern beforehand.

When to Start Planning for a Mock FDA Inspection/Audit

Securing an auditor to conduct a mock FDA inspection/audit should ideally begin several months in advance of the desired audit date.

The exact timing can vary based on the complexity of your organization's operations, the availability of the chosen auditor or auditing team, and the level of preparedness your organization currently has.

• If your organization has never undergone a mock FDA inspection/audit or it has been several years since the last one, you may want to start the process as early as 6 to 9 months in advance. This allows ample time for selecting an appropriate auditor, negotiating terms, and allowing the auditor sufficient time to understand your business, products, and regulatory landscape.
• For companies that regularly conduct mock audits, the process might start 3 to 4 months in advance. These companies usually have established relationships with firms that supply and manage auditors and a good understanding of their own needs, which can speed up the selection and preparation process. (If you need to conduct an audit sooner than this, we can accommodate tight timelines, too. Unlike generalist firms, we can deliver right-fit consultant CVs for consideration in as little as 26 hours.)

Remember that the purpose of these audits is to uncover potential issues well in advance of an actual FDA inspection. Err on the side of starting the process early. This provides your organization with ample time to address any findings and make necessary improvements.

What to Look for in an Auditor

When selecting a consultant to serve as a mock FDA auditor, they should have deep knowledge of the FDA's processes, regulations, and expectations.

They should also have experience in conducting FDA inspections, ideally, but not necessarily with a background as an FDA investigator or in a similar regulatory role. If your company operates in a specific healthcare industry sector (pharmaceuticals, medical devices, biotech, etc.), the auditor should have industry-specific experience.

A great auditor will also be able to communicate clearly and effectively in writing and verbally. They should be able to explain complex regulations in a way that's easy to understand and implement.

Other characteristics include:

• Professionalism and Integrity: The auditor should have a reputation for professionalism and integrity. They should be able to maintain confidentiality, provide unbiased feedback, and uphold the highest standards of ethical conduct.
• Methodical Approach: The auditor should have a systematic and methodical approach to conducting audits. They should be detail-oriented and able to identify both major and minor compliance issues.
• Strong Analytical Skills: A good auditor should have strong analytical skills, enabling them to interpret complex regulations, understand how they apply to your organization, and determine the best way to achieve compliance.

Three Mock FDA Inspection/Audit Best Practices

We're often asked how best to prepare for a mock FDA inspection/audit before a consultant arrives. Here are the three best practices we prescribe most often that are most widely applicable to all firms:

#1: Prepare your documentation thoroughly

All relevant SOP), product specifications, QMS records, training records, and any previous audit findings and corrective actions should be up-to-date, organized, and readily accessible for the mock FDA inspection.

It's also important that your team understands where these documents are located and how to retrieve them swiftly. This helps simulate the real inspection scenario where inspectors may request any document at any time—and expect staff to know where those documents are at all times.

#2: Proactively train and practice audit/inspection communication

Before the mock inspection, ensure all personnel know that such an audit will take place and what it will entail in detail. This can help minimize disruption and stress on the day of the inspection.

Staff should be trained on how to interact with the auditor. They should be prepared to answer questions clearly and concisely and avoid speculating or guessing when they do not know the answer. They should also know not to volunteer information beyond what is asked. Practice sessions can be useful to simulate this environment.

#2: Prepare the physical components of your facility

The team should ensure that the physical facilities are clean, organized, and in compliance with relevant GxPs.

Any issues with facilities, such as maintenance or housekeeping problems, should be addressed prior to the inspection. Also, consider the path that the auditor will take during their tour of the facilities and think about what they will observe along this path. Chart it out and rehearse.

Final Thoughts and Next Steps

Here are the five critical points to take away from this guide:

1. Mock FDA inspections are proactive measures to assess your company's readiness for a real FDA inspection. They reveal strengths and areas of potential weakness within your organization's regulatory compliance framework, helping you to mitigate risks and drive continuous improvement.
2. The process involves thorough planning and preparation, including gathering documents, preparing personnel for interviews, and setting a realistic schedule. It's essential to engage experienced auditors familiar with FDA processes and regulations.
3. The results of a mock FDA inspection should be used as a diagnostic tool for action and training. They guide the remediation of non-compliance issues, improve inspection readiness, and can contribute to broader risk management. Regular mock inspections can also help embed a culture of quality and compliance.
4. Always apply best practices in preparation for a mock FDA inspection/audit. This involves creating a conducive environment for the auditors, educating all staff about regulations and the audit process, preparing a clear narrative about your company's compliance journey, anticipating questions ahead of time, and ensuring thorough documentation and physical facility readiness.
5. Invest time and resources in selecting the right auditor. The right auditor should have deep knowledge of the FDA's processes and regulations and relevant industry experience. A good auditor should also possess strong communication and analytical skills, professionalism, integrity, and a methodical approach.

Mock FDA inspections are an invaluable tool for enhancing your company's regulatory compliance and preparedness for real FDA inspections. However, maximizing the benefits from such an exercise requires careful planning, execution, and follow-up. Engaging with experts who understand the process and regulations intimately can make a significant difference.

At The FDA Group, we have a deep bench of professionals, including many former FDA personnel, who conduct thorough mock FDA inspections and provide remediation assistance and ongoing support to ensure your organization's continual compliance. Contact us today to access our industry-leading auditing services and make your FDA compliance journey smoother and more efficient.

Learn more about our mock FDA inspection services.