A key to successful facility inspection and avoiding enforcement actions is the implementation of robust quality management systems.

FDA maintains metrics for enforcement activities and provides resources for industry that offer insight into trends that can assist in proactively enhancing your quality management systems. This includes:

• Inspections, Compliance, Enforcement and Criminal Investigation searchable database for of enforcement letters (fda.gov\ICEC)
• Center for Devices and Radiological Health (CDRH) Resources for Industry (fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm)
• Center for Drug Evaluation and Research (CDER) Data base for Warning Letters (FDA.gov\Drugs)

To access our white paper discussing inspectional obervation trends for Medical Devices, fill out the form below!