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.
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.
Mislabeling, lack of sterility, sub- and superpotent drugs. Here are the latest recalls.
This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
Last week there were a handful of recalls due to the presence of NDEA. Here are the latest.