The FDA released its quality system inspection data for 2014 this week, reporting a higher number of inspections, but less warning letters sent compared with 2013.
In 2014, the Agency said it inspected 2,213 medical device quality systems, slightly higher than the 2,201 the agency reported inspecting in 2013.
The FDA produced less warnings letters with quality system citations in 2014, however, only clocking in 121 letters sent for the year, compared with 144 in 2013 and 164 in 2012. Of the quality system warning letters issued, 63% were domestic and 37% were foreign, the agency reported.
The agency reported 1,619 inspections of quality systems for domestic devices and 594 for foreign devices in 2014. That’s the most foreign device quality systems the FDA has inspected on record, but the lowest number of domestic inspections since 2009, when the agency reported 1,509 inspections.
Top foreign inspection locations in 2014 were China, with 190, Germany with 72 and Japan with 37. Along with those 3, Taiwan, Switzerland, Canada, Ireland, South Korea, the U.K. and France made up the top 10, the FDA said.
The agency said it “has been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly.”
Between 2008 and 2014, 52% of domestic inspections required no action, the FDA stated. Official action was required on only 8% of inspections, and voluntary actions were required as a result of 40% of the agencies inspections.
For foreign inspections, the numbers were similar for no action and voluntary action indications at 42% and 43% respectively. The number of devices that required official action was nearly double that of domestics at 15%.
In 2014, 1,106 Form 483s were issued by the FDA, with 3,740 quality system deficiencies sited in the reports, up from 3,541 deficiencies reported in 2013.
The post FDA 2014 quality system inspections up from 2013, warning letters down appeared first on MassDevice.
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