Two-Way Conversation Can Improve Inspection Outcome

Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says.

Firms should confirm the scope of the inspection and ask for specifics on what the investigator will be reviewing, says William MacFarland, director of the Center for Devices and Radiological Health’s Division of Manufacturing and Quality. They also should ask how they can help investigators by having documents ready and moving the inspection along in a timely fashion.

It is never a good idea to become resistant right away, MacFarland warns. Not doing what you can to help and answering questions defensively, or not at all, can start an inspection off on the wrong foot. MacFarland served on a panel of experts who spoke about best and worst inspection practices during FDAnews’ recent Medical Device Quality Congress in Bethesda, Md.

Julie Larsen, director of inspection readiness services at BioTeknica, says the best step devicemakers can take to prepare for inspections is to define employees’ roles and train them accordingly. One of the worst things a firm can do is to not document and keep track of investigator requests.

Larry Kopyta, vice president of quality assurance and regulatory affairs at Omnyx, says firms should have standard operating procedures in place and ensure staff are trained properly and behave appropriately during the inspection.

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