FDA Hands Out More Warning Letters, Recent Study Claims

According to a new report released by the Emergo Group, a medical device consulting firm based in Austin, Texas, there has been a steady rise in Form 483 observations and warning letter citations to medical device companies from the U.S. Food and Drug Administration (FDA) since 2008. FDA officials conducted 1,423 quality system inspections at medical device manufacturers in 2008, compared with 2,121 in 2011 and 2,087 in 2012. Emergo’s study looked at data from 2005 onward.

A Form 483 is issued by an FDA field investigator after an on-site inspection and lists any deficiencies found in a company’s quality system.

The main issues FDA has noted in warning letters suggest that companies need to pay closer attention to corrective and preventative action (CAPA) and production and process controls (P&PC). CAPA and P&PC issues each accounted for 30 percent of Form 483 observations last year, well ahead of management, design and document controls.

Quality system observations resulting in citations also have dramatically increased since the FDA began its more aggressive inspection schedule in 2009. Since then, the number of warning letters has climbed steadily, with the single biggest increase between 2011 and 2012. Emergo’s report suggests that the increase in citations is due more to the higher frequency of inspections than a slump in quality system compliance among medical device manufacturers.

Emergo analysts predict that this trend will continue throughout President Obama’s second term in office. The connection between elevated FDA activity and Obama’s presidency is easy to make because the Medical Device User Fee Amendment (MDUFA) was reauthorized under his administration; however, this may well have happened under a different president. MDUFA requires higher fees paid to the FDA from medical device companies, which not only has sped up device review times, but also allowed the agency to hire more personnel and operate more efficiently.