FDA Questions Data Integrity at Ningbo Smart
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co.
Food Safety Auditors’ Red Flag: No Documented Issues
Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management.
Killing Time: How to Manage Interruptions
Read this. It won’t be a waste of time.
Are You Prepared for Foreign Food-Supplier Verification Laws?
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor
Are You Prepared for Foreign Food-Supplier Verification Laws?
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor
Consent Decrees—When the FDA Gets Tired of Talking
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a disc
Consent Decrees—When the FDA Gets Tired of Talking
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a disc
Tips on Preparing for an FDA Inspection
If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S.
Congressional Committee to Reduce Waste, Eliminates Self
It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly.
QC, QA, Sensationalism, and “Seasoned Ground Beef”
The recent brouhaha involving a class-action suit against Taco Bell alleging that their beef filling is more filling than beef really got me thinking, but not about what’s in the tacos.