Facility Registration, Import Problems Keep CDRH Compliance Office Busy
This article was originally published in The Gray Sheet
Executive Summary
CDRH Compliance Director Tim Ulatowski gave an update last week on activities at his office, including import safety efforts and a notable warning letter push
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Hamburg Seeks To Rebuild FDA After Years Of Insufficient Resources
FDA needs more funding to make up for years of neglect, Commissioner Margaret Hamburg said Feb. 8 at the AcademyHealth National Health Policy in Washington, D.C
Regulatory News In Brief
PREDICT at borders: FDA hopes to have its new border inspection tool, Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting, up and running nationwide by spring, Commissioner Margaret Hamburg said Feb. 4. The IT system considers various characteristics to pinpoint shipments in need of more comprehensive inspection and items that are less risky. It has been piloted for food inspections since 2007 and more recently for device and drug shipments (1"The Gray Sheet" Oct. 19, 2009)