CDRH Calendar Year 2016 Data

Calendar year data for the Center for Devices and Radiological Heath data has been released and is available here.

Some highlights from the report:
  • There were 1450 Domestic and 725 Foreign inspections in 2016.
  • Overall 52% of the inspections resulted in NAI – No Action Indicated, 39% resulted in Voluntary Action Indicated, and 9% resulted in Official Action Indicated.
  • 854 FDA Form 483s, containing 3,027 citations for 21 CFR 820 were issued in 2016
  • Hot topics on all inspections for each of the quality system elements included:
    • CAPA 1017 observations 34%
    • Production and Process Controls 964 observations 32%
    • Design Control 382 observations 13%
    • Management 347 observations 11%
    • Document Controls 317 10%