FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
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.
An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.