Background
FDA has long maintained that it has seen a troubling increase in the number of quality-related deficiencies during its facility inspections, prompting it to rethink how it approaches regulation in general.
Its recently proposed approach, which it has dubbed the “Case for Quality,” is built on the premise that an increased emphasis on building quality practices in industry will allow for FDA to focus less on compliance activities. For example, companies utilizing root cause analysis and designing quality into a product are unlikely to experience recurring compliance issues, whereas a company that fixes compliance issues on a piecemeal basis is likely to experience regular problems and recurring product failures.
But if quality is the future that allows for a decreased emphasis on compliance measures, that doesn’t mean FDA isn’t still laser-focused on those issues.
Analysis: Quality Deficiencies Rampant
In a new analysis report issued by Emergo, the consultancy finds that quality system-related inspections have been increasing dramatically in recent years. Since 2008, when FDA conducted 1,423 inspections, the agency had increased its quality-related inspection by more than 46%. That increase was as high as 49% in 2011, when the agency conducted 2,121 inspections, but fell slightly in 2012 to 2,087.
And more inspections have correlated closely with increased warning letters sent to manufacturers. Emergo found an increase of Warning Letters from 98 in 2008 to 164 in 2012—an increase of 67% in just four years. The four consecutive increases (2009-2012) contrast sharply with the 2004-2007 period, when the issuance of warning letters fell each year, from 113 in 2004 to just 74 in 2007.
FDA’s findings of deficiencies in 2012 fall into four areas, of which two are especially prominent: Corrective and preventive action (CAPA) and Production and Process Controls (P&PC), both of which accounted for 30% of all cited deficiencies. The remaining 40% of citations were for design problems (DES) (15%), management issues (14%) and “other” problems (11%). FDA’s observations during 2012 totaled 4,243, according to Emergo’s analysis.
Take-Aways
So what should medical device manufacturers take away from the data? A few things, wrote Emergo’s Stewart Eisenhart. “Medical device firms should expect the trend of stepped-up FDA inspections to continue through the Obama administration’s second term. However, the data also provides a clear indication of which QSR quality system components most commonly draw scrutiny from inspectors.” “Medical device manufacturers active in the US market now know to pay particular attention to their CAPA and P&PC procedures to ensure compliance with 21 CFR Part 820,” he concluded.
REFERENCE: Alexander Gaffney, RF News Editor; RAPS; 13 May 2013