FDA Mock Inspections

Our Lawyers and Consultants Help FDA-Regulated Companies Conduct Mock Inspections So That They’re Prepared for the Real Thing

The U.S. Food and Drug Administration (FDA) regularly conducts inspections in order to assess companies’ compliance with the Food, Drug, and Cosmetic Act (FDCA) and all other pertinent laws and regulations. Medical device manufacturers, pharmaceutical companies, and other FDA-regulated entities can face inspections at various stages—from the premarket submission process through the FDA’s postmarket surveillance focused on ensuring consumer and patient safety. These inspections can present substantial risks, so companies need to be confident that they are prepared. A key step in this process involves conducting mock FDA inspections.

Conducting an effective mock FDA inspection requires a clear and comprehensive understanding of what the FDA inspectors will be looking for when it scrutinizes the company’s facilities and operations during a real FDA inspection. At Oberheiden P.C., our team has experience not only advising companies regarding FDA regulations compliance, but also conducting inspections at the FDA. With a former FDA Director of Compliance and former FDA Investigator on your side, you can be confident that your company’s mock inspections are providing an accurate assessment of its risks during an actual FDA inspection—and you can update your company’s FDA compliance program, taking corrective and preventive actions accordingly.

5 Important Reasons to Conduct FDA Mock Inspections

Conducting FDA mock inspections is about much more than just “checking a box” on your company’s regulatory compliance checklist. When conducted appropriately, mock inspections afford several direct benefits, including:

1. Identifying Any Compliance Program Shortcomings Before They Lead to Problems

The last thing you want during an FDA inspection is a surprise. These surprises are rarely good—and, more often than not, they cause substantial setbacks in companies’ efforts to market FDA-regulated devices, drugs, and other products. By conducting FDA mock inspections, companies can identify any shortcomings in their compliance programs before these shortcomings lead to problems.

2. Ensuring Compliance with All Applicable FDA Laws and Regulations

Conducting mock inspections also allows companies to ensure compliance with all applicable FDA laws and regulations. FDA-regulated companies need to prioritize compliance, and they need to be confident in all aspects of their compliance programs.

3. Generating Documentation of the Company’s Good-Faith Compliance Efforts

Along with ensuring compliance, conducting FDA mock inspections also allows companies to generate documentation of their good-faith compliance efforts. When the FDA conducts inspections, it expects companies to be able to affirmatively demonstrate compliance, so this documentation is crucial. Simply having documented policies and procedures isn’t enough—companies must also be able to show that they are taking proactive steps to implement these policies and procedures on an ongoing basis.

4. Avoiding Unnecessary Risks, Costs, and Delays Due to FDA Inspections

If the FDA uncovers compliance failures during an inspection, this can lead to risks, costs, and delays that could—and should—have been avoided. Mock inspections serve to help companies avoid these issues, bring their products to market as quickly as possible, and keep them on the market post-FDA authorization or approval.

5. Maximizing the Profitability of the Company’s FDA-Regulated Business

Ultimately, by maximizing the efficiency of the premarket submission process and ensuring that companies’ products won’t be subject to recalls or market withdrawals, FDA mock inspections help to maximize the profitability of companies’ FDA-regulated business. At Oberheiden P.C., we prioritize cost-effectiveness, and we rely on our lawyers’ and consultants’ experience to conduct mock inspections that drive value for our clients.

FDA Mock Inspections: Our Process

As a law firm with a network of compliance consultants that includes former FDA personnel, we are able to conduct mock inspections differently from most other organizations. Unlike non-law firms, we are able to provide legal advice during (and after) the process. Additionally, unlike law firms that do not have former FDA personnel on their team, we are able to provide insights based on first-hand experience of how FDA inspections work from the inside out.

With this in mind, while we take a highly custom-tailored approach to legal representation, our process for conducting FDA mock inspections generally involves:

1. Assessing the Scope and Nature of Our Client’s FDA-Regulated Operations

For FDA-regulated entities, the risks they face during an inspection depend on several unique aspects of their FDA-regulated operations. As a result, before we do anything else, we begin by identifying the scope and nature of our clients’ operations that are subject to the FDA’s oversight.

2. Examining Our Client’s FDA Compliance Program, Practices, and Procedures

Another key preliminary step in the process involves examining our client’s FDA compliance program, practices, and procedures. The FDA will examine these as well, so companies need to be confident that they are capable of withstanding the Administration’s scrutiny. If we identify any substantial shortcomings, we help our client address these shortcomings before conducting our mock inspection.

3. Developing an FDA Mock Inspection Plan and Strategy

Since each company’s FDA-regulated operations are unique, each FDA mock inspection requires a custom-tailored plan and strategy. We develop our mock inspection plan and strategy based on what we believe the FDA would do in preparation for conducting a real-world inspection.

4. Conducting the Mock Investigation

Once we’ve laid the groundwork, we will conduct an FDA mock inspection. This will involve examining all aspects of the company’s facility, quality standards, manufacturing and packaging processes, documentation practices, and other relevant practices and procedures. It will also involve conducting mock interviews, document requests, and other investigative steps that the FDA will take when it assesses the company’s compliance.

5. Going Over the Results and Outlining Next Steps

Finally, after completing the FDA mock inspection process, we will go over the results with our client and outline our client’s next steps. Depending on the circumstances, these next steps could range from maintaining the status quo to implementing new or revised FDA compliance policies and procedures. Here, too, we take a custom-tailored approach focused on helping our client establish, maintain, and document full FDA compliance based on its specific risks and needs.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: Conducting Mock Inspections to Assess and Document FDA Compliance

Schedule an Appointment with the FDA Compliance Team at Oberheiden P.C.

If you would like to know more about our mock inspection services for FDA-regulated entities, we encourage you to get in touch. To schedule a complimentary initial consultation with a senior lawyer or consultant at Oberheiden P.C., please call 888-680-1745 or request an appointment online today.