FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…
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.
An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.