Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Continue reading
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
The government is still shut down, though the FDA is still about half-open. The question is: which half?
The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading
The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies. Continue reading