The FDA Just Called! Are You Ready for an Inspection?

If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual? FDA audits can be stressful, and failing one can have significant consequences. With proper preparation, however, the call to schedule an FDA inspection doesn’t have to be so unnerving.

There are different types of FDA inspections, including:

• Routine FDA inspections, which may afford two weeks’ advanced notice to provide time to prepare.
• For-cause FDA inspections, which may stem from specific complaints and are usually unannounced.

If you receive the phone call from the FDA scheduling a routine inspection, it’s important to immediately view the looming inspection as an all-hands-on-deck opportunity. “That moment in time is a real opportunity for a reality check – for really determining what your current state is, what you need to do and what you can do in the time you have before the FDA will arrive,” according to Linda Chatwin, who heads the Medical Devices Regulatory Services section of UL in North America.

Inspection preparations can be grueling. Following the FDA Quality System Inspection Technique (QSIT), the inspector assesses an organization’s systems, methods and procedures to ensure a quality management system (QMS) is established and maintained effectively. The FDA inspection process typically involves observing employee activities, interviewing employees, reviewing records and looking at documented procedures and requirements to assess how they all fit together in the quality system.

In some cases, even two weeks is not enough time for companies to prepare for a routine inspection. And in the case of a for-cause audit, the lack of advanced notice can be particularly stressful. Rather than scramble to prepare everything and everyone when the FDA comes calling, it’s better to maintain a constant state of readiness before that phone call even occurs.

“The best way to survive an FDA inspection is to always be prepared for it,” according to Chatwin, who offered some insight into FDA audit readiness in a webinar with compliance and risk consultant Walt Murray.

Tips to Help Maintain a State of FDA Audit Readiness

Any company in the life sciences should have an FDA policy and procedure in place. As part of an organization’s audit plan, there should be an FDA audit checklist, appropriate teams should be identified, and team members should understand their roles and responsibilities relating to inspections. Site personnel should be aware of – and even trained in – FDA inspection procedures, which items to have ready during an inspection and how to interact with the FDA investigator. To reinforce its commitment to the policy, company leadership should ensure that employees receive ongoing training on the policy and procedures.

(Remote audits require more planning and preparation. For guidance on participating in remote audits, see "Conducting Audits at a Social Distance" and "Remote Audits Reignite Regulated Companies and Supply Chains.")

In the webinar, Chatwin and Murray highlighted three tools that can help organizations maintain a constant state of audit readiness:

• Internal audits – It’s important that your organization maintains a robust and well-organized internal audit program, and that internal audit results are continuously monitored and reviewed to determine if there are recurring problems or new problems in areas that weren’t addressed during previous audits. Plus, having a history of internal audits indicates to the FDA that your organization understands quality requirements and takes its quality system seriously.


• Mock Audits – Vigorous mock audits can reveal possible quality system gaps that can then be resolved. “Conducting mock FDA audits is an excellent way to keep in a state of readiness and help employees in the organization understand what it would be like when the real FDA comes and audits [your organization],” according to Chatwin. Done properly, conducting mock audits can boost site staff’s confidence during inspections.


• External audits – Having some experience with previous external audits (e.g., customer, supplier, FDA), and applying lessons learned from those, can also help. Often, medical device companies already have customers auditing them regularly, which can serve as learning opportunities, and conducting supplier audits can give you some ideas of what to include in your own internal audit program.

These three types of audits can provide insight into areas where operations can be improved. However, because an audit is a sampling of activities at a point in time, it’s difficult, if not impossible, to examine every single process, practice and procedure during any given audit. Even if you have external or mock audits, it is important to monitor and review internal audit results for previously unaddressed problems.