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Jan 27, 2016

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

If the FDA calls to schedule an 
inspection, will you be prepared?

by David R. Butcher

Marketing Communications, MasterControl


If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

In a recent webinarUnderwriters Laboratories’ (UL) Linda Chatwin and MasterControl's Walt Murray shared their wisdom on the value of FDA audit readiness.

There are different types of FDA inspections, Murray, director of MasterControl’s Quality and Compliance Consulting services, explained. “For cause” inspections, which may stem from complaints, are usually unannounced. Pre-announced “routine” inspections are more typical and may afford advanced notice of up to two weeks or more “to provide time to prepare for the inspection,” 

If you receive the phone call from the FDA scheduling a routine inspection, you’ll want to immediately look at the looming inspection as “an all-hands-on-deck opportunity,” according to Chatwin, who serves as regulatory affairs consultant for UL’s Advisory Services group. “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.”


This article is related to the Whitepaper: 21 CFR Part 11 Industry Overview - Ready for an FDA Inspection? To get the full details, please download your free copy.


Inspection preparations can be grueling. Following the Quality System Inspection Technique (QSIT), the FDA inspection assesses an organization’s systems, methods and procedures to ensure a QMS is established and maintained effectively. The 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 simply is not enough time for companies to prepare for a scheduled inspection. Rather than scramble to prepare everything and everyone when the FDA’s phone call comes, 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 along with Murray offered some insight into FDA inspection readiness.

Tips to Help Maintain a State of Audit Readiness


“It’s important that your organization has an existing FDA policy and procedure in place,” Chatwin said. As part of an organization’s “How to Handle an Audit” plan, 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, what items to have ready during an inspection and how to interact with the FDA. To reinforce its commitment to the policy, company leadership should ensure that employees receive ongoing training on the policy and procedures.

In the webinar, Chatwin and Murray highlighted three tools that can help organizations keep in a constant state of inspection 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 you understand quality requirements and take your 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, performing 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. “Of course, anybody in the medical device business is having customers coming in and auditing them on a regular basis,” Chatwin said. “Also, performing supplier audits helps keep in mind some of the ideas that we need to include in our own internal audit program.”
These three types of audits should be considered learning experiences, providing 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, Chatwin stressed the importance of monitoring and reviewing the results of internal audits to determine if there are recurring problems or new problems in areas that weren’t addressed during previous internal audits. 

To learn more about how to be prepared for an FDA inspection, watch the complimentary webinar FDA Just Called! Now What?


David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.









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