How to Prepare for an FDA Inspection Audit: 7 Steps
The U.S. Food and Drug Administration (FDA) does much more than approve foods and drugs for sale. Among other mandates, it is also tasked with enforcing companies’ obligations under the Federal Food, Drug, and Cosmetic Act and other sources of authority, and it is extremely active in its enforcement efforts. One of the FDA’s primary means of enforcement is conducting inspections and audits.
As the FDA explains, the agency, “inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations.” Those that may be subject to FDA inspections and audits include:
- Animal feed processors
- Blood banks
- Compounding pharmacies
- Dairy farms
- Drug and vaccine manufacturers
- Facilities that conduct clinical trials
- Facilities that conduct studies in animals or microorganisms
- Food processing facilities
- Foreign facilities that manufacture or process FDA-regulated products
- Importers of FDA-regulated products
If your company falls into any of the above categories and either (i) is in the process of seeking FDA approval, or (ii) currently manufactures or processes an FDA-regulated product, then it must be prepared to deal with inspections and internal audits. So, what do you need to do?
7 Steps to Prepare for an FDA Inspection Audit
Far too many companies take a wait-and-see approach when it comes to FDA inspections and audits. Typically, this is because the company’s leaders either (i) assume everything will be fine, or (ii) don’t know where to begin, and decide to let the chips fall where they may. While companies that take this approach may eventually get through the inspection or audit process, the process will be far more expensive and time-consuming, and it is highly unlikely that they will come out unscathed.
When it comes to successfully completing an inspection or audit, thorough preparation is key. There is simply no substitute for knowing what to expect and planning ahead. With this in mind, all companies that are subject to the FDA’s oversight should:
1. Develop a Good Working Relationship with FDA Compliance and Defense Counsel
Successfully completing an inspection or audit requires a comprehensive understanding of a company’s compliance obligations as well as the FDA’s inspection and audit procedures. As a result, this is not a task companies can handle on their own. Instead, they must engage outside FDA compliance and defense counsel to advise and represent them throughout the process.
Rather than engaging counsel when an inspection or internal audit arises, it is best to develop a good working relationship with a team of experienced lawyers who have an in-depth understanding of your company’s operations and the products it manufactures or processes. This serves two related and equally-important purposes: (i) it affords the company’s leaders and in-house lawyers the ability to pick up the phone and seek guidance whenever necessary, and (ii) it ensures that the company’s outside lawyers are able to provide tailored advice focused on the company’s specific risks and needs.
2. Conduct a Comprehensive Internal FDA Compliance Assessment
Working with their outside counsel, companies should conduct comprehensive internal FDA compliance assessments. As a general rule, these assessments should be conducted initially upon engaging outside counsel and then on an annual basis thereafter. Company leaders, in-house lawyers, and subject matter experts should all be involved in the process of outlining the assessment plan, and the goal should be to gain a comprehensive and unbiased understanding of both the adequacy (in terms of scope) and the efficacy of the company’s FDA compliance program.
When conducting an internal compliance assessment, working with outside counsel ensures that all communications and documentation generated during the process will be protected by the attorney-client privilege. This is imperative; as, without this protection, these communications and documentation could be subject to review by the and/or in litigation. If an internal FDA compliance assessment uncovers any compliance deficiencies, these deficiencies should be addressed properly through appropriate means (i.e. re-training the employees involved or updating the company’s compliance program, as warranted by the circumstances involved).
3. Know What to Expect During an FDA Audit
The FDA has published several Inspection Guides, and it also makes its 541-page Investigations Operations Manual publicly available. This means not only that companies can use these materials to prepare for inspections and audits, but that the FDA expects companies to be familiar with these documents’ contents. Of course, this is easier said than done—and this is why companies rely on outside counsel rather than attempting to manage compliance, inspections, and audits on their own.
Working with outside counsel, company leaders and in-house lawyers should take the time to understand what to expect during an inspection or audit. These inspections and audits can be extraordinarily in-depth, and they can cover all aspects of companies’ operations—from how they clean their facilities to how they label their products. Knowing what to expect allows company executives and counsel to avoid surprises, which is important as surprises during inspections and audits rarely work out in the company’s favor.
4. Develop the Company’s FDA Inspection Protocol and Assemble a Response Team
Responding to FDA inspection audits should be a systematic process that is managed and overseen by a team of individuals who all have well-defined roles. To this end, companies should develop inspection protocols, and they should assemble response teams that are composed of appropriate internal personnel as well as attorneys from the company’s outside compliance and defense firm. Internal team members should generally include executives (i.e. the COO), in-house lawyers (either the company’s General Counsel or an Associate General Counsel with relevant knowledge and experience), and subject-matter experts who are capable of assisting with the company’s response.
An inspection protocol should outline the preliminary steps to be taken in response to FDA audits. It should also define each team member’s role (which should be understood by the team member in advance) and establish a chain of command. The goal is to ensure that the company’s response is just as organized and effective as, if not more organized and effective than, the inspection or audit itself.
5. Conduct a Simulated FDA Audit
After developing an FDA inspection protocol and assembling a response team, it can be extremely beneficial to conduct a simulated inspection or audit. Since the company’s internal FDA compliance audit should have uncovered any compliance deficiencies (which should at this point have been remedied), the purpose of this simulation is not necessarily to assess the company’s FDA compliance program, but rather to assess the effectiveness of its inspection response protocols.
In order to serve its intended purpose, a simulated inspection or audit should be as realistic as possible. With the company’s lawyers serving in the role of an FDA inspector, the company should run through the initial stages of an inspection based on the protocols it has developed. Are there any holes or flaws? Is there confusion among team members? Are there any gaps in communication? If so, these are issues that should be addressed before FDA inspectors knock on the company’s door.
6. Monitor the Company’s FDA Compliance Efforts on an Ongoing Basis
The FDA conducts three types of inspections: (i) pre-approval inspections, (ii) routine inspections of regulated facilities, and (iii) “for-cause” inspections triggered by specific events. Given the ongoing potential for facing FDA scrutiny, it is imperative for companies to monitor their compliance efforts on an ongoing basis.
By monitoring their FDA compliance efforts, companies afford themselves the opportunity to address any issues promptly when they arise. This helps to avoid surprises during FDA audits. It also helps to establish good-faith efforts to maintain compliance in the event of a follow-on FDA fraud investigation.
7. Implement the Company’s Response Protocol Promptly When Contacted By the FDA
Finally, when the time comes, companies should promptly implement their inspection response protocols when contacted by the FDA. Based on their simulated inspections or audits, companies should be well-prepared, and the members of their response team should know exactly what they need to do. Crucially, they should have a clear understanding of what not to do (and what not to say) as well. Any unexpected inquiries should be referred to the company’s counsel, and members of the response team should meet as necessary in order to ensure a coordinated and effective response.
Ultimately, while FDA inspection audits can be costly, this does not have to be the case. By taking the steps necessary to prepare in advance, companies that are subject to the FDA’s oversight can streamline the inspection process and set themselves up for success.
Speak with an FDA Compliance and Defense Lawyer at Oberheiden P.C.
If your company is subject to the FDA’s oversight and you have questions about what your company can (and should) be doing to prepare for an FDA inspection audit, we encourage you to get in touch. To speak with a senior FDA compliance and defense lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or get in touch online today.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.