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%