FDA Warning Letter Data Shows Improvement in 2013

The FDA has released its annual Medical Device Quality System Data report concerning Form 483 and Warning Letter Citations, and there’s some good news to be found in the official report. Specifically, for the first time in four years the agency has reported a decline in the overall number of warning letters issued to medical device companies. Only 144 warning letters were issued for the 2013 calendar year, which represents a drop of 20 letters compared to the year before.

144 warning letters translates into 16 percent of all foreign firms being inspected having some type of quality system violation, with 4 percent of inspected domestic firms contributing the rest. Most often, the FDA cited these organizations for corrective and preventive action procedures under 21 CFR 820.100(a), but complaint files and quality audit procedures were also common causes for a warning letter to be issued. In total, 2,201 medical device manufacturers were inspected during the course of 2013, which represents a 3 percent decrease versus 2012, but more importantly, the FDA noted 17 percent fewer inspectional observations during its inspections, which indicates an improvement in quality systems across the board.

Why publish this data? The FDA and the CDRH are continuing their push for greater transparency in operation, and making this type of information public not only fulfills that mandate, but also assists companies in pinpointing areas where they might come up short from a regulatory perspective. The most commonly-cited violations provide a lens through which a medical device manufacturer can view its own operations and push for tighter adherence to current requirements, thus avoiding the potential for a future warning letter of their own.

It would be a mistake to think that a small decrease in the number of FDA inspections for 2013 means that future years will bring progressively fewer industry inspections. An accent on foreign inspections, which require more resources, contributed to the slight sag in numbers for the FDA that year, and an increase in agency funding for 2015 points to a spike, rather than a continued decline in medical device facility inspections. Note, too, that the number of warning letters for 2013, while fewer than 2012, is actually double what was issued in 2009. Maintaining a consistent quality system is more important now than ever whether bringing a new medical device to market or supporting an existing product.


  • Medical Device