CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?
Here we look at the interval between inspection and issuance of warning letters and the interval between inspection and issuance of import alerts for FY2018 drug GMP warning letters.
The global supply chain for drug products has become increasingly more complicated, and as such has expanded the scope of sites FDA must routinely inspect.
After fifteen years of zero FDA enforcement activity, Immunomedics was hit hard not once, but twice in one month. The second punch was concerning enough to thrust them into the spotlight, causing their stock to be sold and their shares to plummet.
The global supply chain for drug products sold in the US has become increasingly more complicated in the past decades.
It's been a light couple of weeks due to the partial government shutdown. Here are the latest recalls.
An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.
FDA sent 2 warning letters to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella.
Mislabeling, lack of sterility, sub- and superpotent drugs. Here are the latest recalls.