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.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
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.
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.
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.