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FDA Investigators Talk Quality Issues And Inspectional ‘Games’ Manufacturers Play

This article was originally published in The Silver Sheet

Executive Summary

There are plenty of typical mistakes that FDA investigators find when inspecting device firms, from failing to adequately document complaints and ensuring proper process validation, to developing ambiguous design inputs during design control activities. Yet what really grates investigators’ nerves is when they have to ask manufacturers several times for procedures and processes that are routinely asked for during an inspection. “Let’s get beyond the things that you know are going to be needed and have them readily available,” says Phil Pontikos, an agency investigator and FDA’s national device expert. In fact, firms that attempt to conceal information or stall an investigator leave themselves open to additional scrutiny by the agency. “If you want to play games, then quite frankly, we’re going to dig deep,” Pontikos says.

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From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish

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.

Year In Review: Complaint Handling, UDI, FDA Inspections, And More

The top quality-related topics manufacturers faced last year included a new FDA regulation to track and trace devices, innovative supply chain initiatives and an update to the agency’s Medical Device Reporting guidance, among others. Plus honorable mentions: product recalls, human factors and FDA compliance meetings.

Record Number Of Warning Letters Issued In 2012; Complaint Handling Troubles Significant

Device manufacturers were sent an historic number of warning letters by FDA last year, eclipsing the previous high from 1997. FDA has not yet completed its own analysis of 2012 warning letter trends, but an ex-agency official says there are several likely reasons for the increase. FDA’s Office of Chief Counsel “is no longer throwing cold water on letters. Investigators are being trained a lot better and are becoming more experienced. And certainly the Office of Compliance and CDRH are under new management. You put all of those things together and I think that’s the answer,” says Michael Chappell, a former FDA associate commissioner for regulatory affairs. The number of foreign warning letters also increased in 2012, comprising 39 percent of overall letters. In another first for warning letters last year, complaint handling supplanted CAPA as the violation found most in letters. Further, four former FDA officials share tips for writing warning letter responses to FDA.

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