BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…
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.
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.