The FDA is coming! The FDA is coming! “This sums up my initial feelings in 2009, when I got the news that FDA was making a trip to our company,” recalls Schevon Salmon, an affiliated attorney. He was in charge of a medical device company’s compliance program during their first FDA facility inspection. Although they were audited every year for ISO 9001:13485, having FDA come in was different. “They had the power to shutter our doors, and with that a key income stream. And like most companies in the same position, we were terrified.”
The thought of an FDA inspection can be terrifying – but, with a bit of preparation, the actual inspection does not have to be. Think of your quality management system as a wheel that is constantly spinning. An inspection is a snapshot of the wheel as it spins. The investigator’s main objective is to ensure devices produced by this constantly-moving system are safe. Your system should be designed to reflect your daily operations, and should be adequate to meet the regulatory requirements. The inspector will evaluate whether your written documentation is adequate to prove that you are compliant.
The interchange between your staff and the investigator should be cordial and respectful. Prepare a designated area where the inspector can review documents and interact with staff without interruption. Designate an individual to interact with the inspector – preferably someone with knowledge of your policies and procedures. A separate individual should be designated to take notes of the entire inspection, like a formal meeting.
A typical device facility inspection starts with an evaluation of how your company evaluates and monitors complaints. The inspector is less interested in the types of complaint at this point than in whether your system has the capacity to identify and properly handle potential safety concerns. How your company handles complaints will set the tone for the respect of the inspection. A good inspector can readily identify problem areas in your entire system from a review of your complaint system. A great complaint system, including well-functioning corrective and preventative policies and procedures, may alleviate any initial concerns regarding the safety of your products.
Finally, log and make duplicates of all documents reviewed by the inspector; this can serve as a handy tool when replying to any observations. When the inspector finishes, accept the affidavits and form 483, but exercise your right to not sign the form.
In the end, Mr. Salmon’s company survived their first inspection with positive results. “We overcame our initial terror with preparation and a winning approach,” he states.
Are you ready for FDA to inspect your medical device facility? Download our free checklist of What to Expect in a Facilities Inspection. Whether you are an experienced compliance director or new to FDA regulated products, this guide arms you with valuable tips.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
