What Congress Could Do About Remote US FDA Inspections That Are Not Inspections
Executive Summary
Now that video site tours can sidestep pandemic travel restrictions, an expert who consults for industry on US FDA inspections suggests Congress may want to revise the FD&C Act to sidestep the “site entry” inspections limitation.
You may also be interested in...
Can We Talk? US FDA Remote Records Review Missteps Worry Industry
Alkermes CRL is just the latest fallout from black-hole process.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.