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.
We all “know” FDA doesn’t cite Part 11 in 483s, right? Well, maybe.
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.
In the past week, we added 33 483s to our database of 27,500+ FDA inspection documents.
Last week there were a handful of recalls due to the presence of NDEA. Here are the latest.
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.
From lack of sterility to discoloration, here are the latest recalls.