Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warning that things "can easily become out of control. You need to find a good ringmaster." Yet a back room isn't the only place manufacturers should be careful about using the right people. Present in the front room – where investigators traditionally work when onsite at a firm – should be helpful, reliable facilitators that aid investigators with requests and answer an array of questions.

The number of recalled device units ballooned to a whopping 372,215,986 in the third quarter of 2021, mostly driven by an August recall of Monoject Flush Prefilled Saline Syringes by Cardinal Health. Check out our Q3 recalls infographic.

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.