An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.
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.
From high concentrations of ibuprofen for infants to a metal shard found in a tablet, here are the latest recalls.
Clinical service provider or CRO? Observations of FDA enforcement.