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

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

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 White Paper:

21 CFR Part 11 Industry Overview - Ready for an FDA Inspection?
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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

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.”