Devicemakers can help to facilitate facility inspections — and improve their inspection experience — by engaging in constructive conversations with agency investigators, a U.S. 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 should also ask how they can help investigators by having documents ready and moving the inspection along in a timely fashion.
On the flip side, 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, he says.
MacFarland was on a panel of experts who spoke about best and worst inspection practices at 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 in a front or back room and then train them accordingly. One of the worst things a firm can do is not document and keep track of investigator requests, she adds. Failing to stay on top of things can slow an inspection and reflect negatively on the company.
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. He also suggests that firms take down any funny posters or other displays to convey a serious tone.
The worst practice Kopyta has witnessed is a failure to organize documents requested by an inspector. He notes how an inspector once asked for a large number of documents and an employee wheeled them in on a cart, stacked up and unorganized in a box. — Kellen Owings