Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief
The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013. This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products. Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.
It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013: Continue reading