Inspection Data and Areas of Emerging Concern

CDRH Publishes 2015 Annual Medical Device Quality System Data

Reviewing and understanding the latest data on inspections, inspectional observations, and Warning Letter citations is critical for life science manufacturers.

In support of the FDA’s transparency and Case for Quality initiatives, FDA’s Center for Devices and Radiologic Health (CDRH) has published data on inspections, inspectional observations, and Warning Letter citations in 2015. FDA believes this information will help industry improve device quality by sharing the most common observations, identifying areas of emerging concern and potentially helping firms avoid receiving Warning Letters.

Click here to access document – 2015 ANNUAL MEDICAL DEVICE QUALITY SYSTEM DATA