Infographic: FDA Medical Device Quality System Data

Inspections, FDA Form 483 Observations and Warning Letter Citations

In support of the FDA’s Transparency and Case for Quality Initiatives, the Center for Devices and Radiological Health (CDRH) provides annual data on inspections, inspectional observations, and Warning Letter (WL) citations issued.

Production and Process Controls, followed by Corrective and Preventive Actions continue to be the most frequently cited QS subsystems.

The infographic below breaks down foreign v. domestic inspection data for Calendar Year (CY) 2015. 


To download a PDF of the infographic, please click here.

To view the report in its entirety, please click here.

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