FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…
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.
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.
In the past week, we added 47 483s to our database of 27,500+ FDA inspection documents.
We compiled last week's warning letters for you. Take a look.