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.
FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
The global supply chain for drug products sold in the US has become increasingly more complicated in the past decades.
Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week.
We put together the ultimate guide that will give you an industry primer for everything you need to know about Form FDA 483s.
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.