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.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
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.